510(k) · Cleared
ClearedVis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steris · FRG Wrap, Sterilization
Cleared on Sep 9, 2022 as substantially equivalent to K183401 (STERIS Corporation, 2019) and 1 other predicate after a 28-day review. Its family tree reaches back 11 generations to 1984. 2 later devices descend from it.
- Decided
- Sep 9, 2022
- Review
- 28 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K844002 (1984). 27 ancestors in all, the oldest K771032 (1977). 2 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 7 generations between
- 3 generations backK160912 Sterilization TraySTERIS Corporation · 2016
- 2 generations backK172755 PRO-LITE Sterilization TraysSTERIS Corporation · 2018
- 1 generation backK183402 PRO-LITE Sterilization TraySTERIS Corporation · 2019
- This deviceK222440 Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE…Steris · 2022
- Descendant · cites it directly · 0 of its ownK231501 PRO-LITE Sterilization TraySTERIS Corporation · 2023
- Descendant · cites it directly · 0 of its ownK231500 Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation · 2023
Show all 11 generations
- Root · 11 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 10 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 9 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 8 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 7 generations backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- 6 generations backK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- 5 generations backK070769 VHP 136 TraySTERIS Corporation · 2007
- 4 generations backK140494 V-Pro Sterilization Tray/ Sterilization MatSTERIS Corporation · 2014
- 3 generations backK160912 Sterilization TraySTERIS Corporation · 2016
- 2 generations backK172755 PRO-LITE Sterilization TraysSTERIS Corporation · 2018
- 1 generation backK183402 PRO-LITE Sterilization TraySTERIS Corporation · 2019
- This deviceK222440 Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE…Steris · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −10 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −9 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −8 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −7 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| −6 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| −5 | K070769 | VHP 136 Tray | STERIS Corporation | 2007 | — |
| −4 | K140494 | V-Pro Sterilization Tray/ Sterilization Mat | STERIS Corporation | 2014 | — |
| −3 | K160912 | Sterilization Tray | STERIS Corporation | 2016 | — |
| −2 | K172755 | PRO-LITE Sterilization Trays | STERIS Corporation | 2018 | — |
| −1 | K183402 | PRO-LITE Sterilization Tray | STERIS Corporation | 2019 | — |
| 0 (this device) | K222440 | Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization… | Steris | 2022 | — |
| +1 | K231501 | PRO-LITE Sterilization Tray | STERIS Corporation | 2023 | — |
| +1 | K231500 | Vis-U-All Low Temperature Sterilization Pouches | STERIS Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1982 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRG device
- #1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K183401 | Vis-U-All Low Temperature Sterilization Pouch/TubingSummary page 12…21 CFR 880.6850 Product Code: FRG 2. Predicate Device Vis-U-All Low Temperature Sterilization Pouches/Tubing, K183401 3. Description of Device The proposed Vis-U-All Low Temperature Sterilization Pouches/Tubing is identical… | 2019 |
| * | K183402 | PRO-LITE Sterilization TraySummary page 22…ation 21 CFR 880.6850 Class II Product Code KCT, FRG 8. Predicate Device PRO-LITE Sterilization Tray, K183402 9. Description of Device The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-… | 2019 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K231501 (STERIS Corporation, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · FRG
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRG
151in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRG
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRG
18in 2025
MAUDE reports naming product code FRG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 182 | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 4 | 171 | 0 | 2 |
| 2010 | 4 | 213 | 0 | 0 |
| 2011 | 6 | 110 | 0 | 12 |
| 2012 | 10 | 133 | 0 | 4 |
| 2013 | 6 | 146 | 2 | 5 |
| 2014 | 8 | 177 | 0 | 13 |
| 2015 | 12 | 196 | 0 | 9 |
| 2016 | 9 | 131 | 0 | 20 |
| 2017 | 9 | 260 | 29 | 7 |
| 2018 | 5 | 150 | 0 | 22 |
| 2019 | 9 | 258 | 0 | 10 |
| 2020 | 5 | 122 | 14 | 21 |
| 2021 | 4 | 170 | 0 | 9 |
| 2022 | 9 | 217 | 2 | 4 |
| 2023 | 9 | 230 | 0 | 13 |
| 2024 | 11 | 182 | 0 | 21 |
| 2025 | 9 | 151 | 0 | 18 |
| 2026 | 4 | 247 | 0 | — |
What is it indicated for?
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose: » medical devices in a single or double pouch configuration » trays* containing medical devices in a single or double pouch configuration » small items requiring surface sterilization in a single pouch configuration within a tray* NOTE: Trays must be legally marketed for use in the V PRO Low Temperature or STERRAD…
Read the full statement (2,641 words)
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:
» medical devices in a single or double pouch configuration
» trays* containing medical devices in a single or double pouch configuration
» small items requiring surface sterilization in a single pouch configuration within a tray*
NOTE: Trays must be legally marketed for use in the V PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio > 0.135 in-1 with the maximum number of instrument organizers installed.
to be sterilized in the:
* Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems
* Default Cycle of the STERRAD 100S Sterilizer
» Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
* Express, Standard, Flex Scope and DUO Cycles of the STERRAD 100NX and 100NX with ALLClear Technology Sterilizers
*STERRAD and ALLClear are trademarks of Advanced Sterilization Products
The pouches maintain the sterility of the enclosed devices until used.
When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.
Intended Sterilization Cycles and Intended Pouch Loads when Medical Devices are:
* Directly pouched
* Placed inside of a tray and the tray pouched
V-PRO 60 & s2 Lumen Cycle
* Non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
* Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
» Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations:
o single or dual lumen devices
> 0.77 mm internal diameter (ID) and <410 mm in length
> 1.8 mm ID x < 542 mm in length
o triple lumen devices
>1.2 mm ID and <275 mm in length
>1.8 mm ID and <310 mm in length
Or
>2.8 mm ID and <317 mm in length
V-PRO 60 & s2 Non Lumen Cycle
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
V-PRO 60 & s2 Flexible Cycle
Load 1: One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:
» single or dual lumen device with lumens that are > 1 mm ID and < 990 mm in length
Load 2: Non-lumened devices including non-lumened rigid semi-rigid, and flexible endoscopes and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors. Medical devices, including rigid and semi-rigid endoscopes, with the following configurations:
>0.76 mm ID and < 233 mm in length
> 1.0 mm ID and <254 mm in length
> 1.8 mm ID and < 542 mm in length
V-PRO s2 Fast Cycle
* Non-lumened devices including non-lumened rigid and semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
» Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:
o single or dual lumen devices
>0.77 mm ID and <410 mm in length
> 1.8 mm ID x < 542 mm in length
» Triple channeled devices with stainless steel lumens that are either:
>1.2 mm ID and <275 mm in length
>1.8 mm ID and <310 mm in length
Or
>2.8 mm ID and <317 mm in length
V-PRO 1, 1 Plus, maX & maX 2 Lumen Cycle
* Non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
* Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
» Medical devices, including single, dual or triple channeled stainless steel lumens that are:
> 0.77 mm ID and < 527 mm in length
> 0.8 mm ID and < 542 mm in length
> 0.48 mm ID and < 100 mm in length
» Medical devices with Dead end lumens that are > 1.3 mm ID and < 73 mm in length
* Devices with rigid non-metallic lumens (such as those used in endoscope sheaths, take-apart forceps and trocars) that are:
>3 mm ID and <298 mm in length
>4 mm ID and < 424 mm in length
V-PRO 1, 1 Plus, maX & maX2 Non Lumen Cycle
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
V-PRO maX and maX 2 Flexible Cycle
Load 1: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
The flexible endoscopes may contain either a single or dual channel lumen that is > 1 mm ID and < 1050 mm in length
Load 2:
* Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors
» Single, dual or triple channel stainless steel lumen that is > 0.48 mm ID and < 100 mm in length.
V-PRO maX 2 Fast Non Lumen Cycle
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
STERRAD 100S Default Cycle
Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Metal and nonmetal lumened instruments with:
> 6 mm ID and <310 mm in length
Medical devices with a single stainless steel lumen with:
> 1 mm ID and < 125 mm in length
> 2 mm ID and <250 mm in length
>3 mm ID and <400 mm in length
STERRAD NX and NX with ALLClear Technology Standard Cycle
Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with a single stainless steel lumen with:
> 1 mm ID and < 150 mm in length
> 2 mm ID and <400 mm in length
STERRAD NX and NX with ALLClear Technology Advanced Cycle
Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical Devices, including most flexible endoscopes, with:
a single stainless steel lumen with:
> 1 mm ID and < 500 mm in length
Single channel polyethylene and Teflon (polytetrafluoroethylene)
>1 mm ID and < 850 mm in length
STERRAD 100NX and 100NX with ALLClear Technology Standard Cycle
Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with a single stainless steel lumen with:
> 0.7 mm ID and < 500 mm in length
STERRAD 100NX and 100NX with ALLClear Technology Flex Scope Cycle
Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical Devices, including most flexible endoscopes, with:
[J Single channel polyethylene and Teflon (polytetrafluoroethylene)
> 1 mm ID and < 850 mm in length
STERRAD 100NX and 100NX with ALLClear Technology Express Cycle
Metal and nonmetal medical devices (surfaces sterilization only) and instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
STERRAD 100NX and 100NX with ALLClear Technology Duo Cycle
Medical devices including:
most flexible endoscopes with a single channel of polyethylene and Teflon (polytetrafluoroethylene) with > 1 mm ID and < 875 mm in length
[J accessory devices that are normally connected to a flexible endoscope during use
[J flexible endoscopes without lumens
The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles:
* Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO Low Temperature Sterilization Systems
* Default Cycle of the STERRAD®* 100S Sterilizer
» Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
» Standard, Flex Scope, Express and DUO Cycles of the STERRAD 100NX and 100NX with ALLClear Technology Sterilizers
*STERRAD and ALLClear are trademarks of Advanced Sterilization Products
Prior to placing in the Sterilizer, the trays must either be:
» wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above
or
» placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above.
The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052
V-PRO 60 and s2 Lumen Cycle:
* Non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors
* Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
» Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes with the following configurations:
o Single or dual channeled devices with stainless steel lumens that are:
> 0.77 mm ID and <410 mm in length
> 1.8 mm ID x < 542 mm in length
o Triple channeled devices with stainless steel lumens that are:
> 1.2 mm ID and <275 mm in length
> 1.8 mm ID and <310 mm in length
or
> 2.8 mm ID and <317 mm in length
V-PRO 60 and s2 Non Lumen Cycle:
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
V-PRO 60 and s2 Flexible Cycle:
Load 1: One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:
» Single or dual lumen device with lumens that are > 1 mm ID and < 990 mm in length
Load 2: Non-lumened devices including non-lumened rigid, semi-rigid, and flexible endoscopes and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors. Medical devices, including rigid and semi-rigid endoscopes with the following configurations:
>0.76 mm ID and < 233 mm in length
> 1.0 mm ID and <254 mm in length
> 1.8 mm ID and < 542 mm in length
Intended Sterilization Cycle and Intended Tray Load for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049
V-PRO s2 Fast Cycle:
* Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes, and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps and scissors.
» Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:
o Single or dual channeled devices with stainless steel lumens
> 0.77 mm ID and <410 mm in length
> 1.8 mm ID and < 542 mm in length
o Triple channeled devices with stainless steel lumens that are either
> 1.2 mm ID and <275 mm in length
> 1.8 mm ID and < 310 mm in length
> 2.8 mm ID and <317 mm in length
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052, VP0053
V-PRO 1, 1 Plus, maX, and maX 2 Lumen Cycle:
* Non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors
» Medical devices, including single, dual or triple channeled stainless steel lumens that are:
> 0.77 mm ID and < 527 mm in length
> 0.8 mm ID and <542 mm in length
> 0.48 mm ID and < 100 mm in length
» Medical devices with dead end stainless steel lumens that are > 1.3 mm ID and < 73 mm in length
* Devices with rigid non-metallic lumens (such as those used in endoscope sheaths, take-apart forceps and trocars) that are:
>3 mm ID and <298 mm in length
>4 mm ID and <424 mm in length
V-PRO 1 Plus, maX, and maX 2 Non Lumen Cycle:
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors
V-PRO maX, and maX 2 Flexible Cycle:
Load 1: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain either a single or dual lumen that is > 1 mm ID and < 1050 mm in length.
Load 2:
* Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors
» Single, dual or triple channel stainless steel lumens that are > 0.48 mm ID and < 100 mm in length
V-PRO maX 2 Fast Non Lumen Cycle:
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052
STERRAD 100S Default Cycle:
Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Metal and nonmetal lumened instruments with
> 6 mm ID and <310 mm in length
Medical devices with a single stainless steel lumen with:
> 1 mm ID and < 125 mm in length
> 2 mm ID and <250 mm in length
>3 mm ID and <400 mm in length
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0048, VP0049
STERRAD NX and NX with ALLClear Technology Standard Cycle:
Metal and non-metal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with a single stainless steel lumen with:
> 1 mm ID and < 150 mm in length
> 2 mm ID and <400 mm in length
STERRAND NX and NX with ALLClear Technology Advanced Cycle:
Metal and non-metal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors
Medical devices, including most flexible endoscopes, with:
o a single stainless steel lumen with:
> 1 mm ID and < 500 mm in length
o single channel polyethylene and Teflon (polytetrafluoroethylene)
> lmm ID and < 850 mm in length
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0048, VP0049, VP0051, VP0052, VP0053
STERRAD 100NX and 100NX with ALLClear Technology Standard Cycle:
Metal and nonmetal medical devices including instruments with have diffusion-restricted spaces, such as the hinged portion of forceps and scissors
Medical devices with a single stainless steel lumen with:
> 0.7 mm ID and < 500 mm in length
STERRAD 100NX and 100NX with ALLClear Technology Flex Scope Cycle:
Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices, including most flexible endoscopes, with:
» Single channel polyethylene and Teflon (polytetrafluoroethylene)
> Imm ID and < 850 mm in length
STERRAD 100NX and 100NX with ALLClear Technology Express Cycle:
Metal and nonmetal devices surfaces and instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
STERRAD 100NX and 100NX with ALLClear Technology Duo Cycle:
Medical devices including:
» most flexible endoscopes with a single channel of polyethylene and Teflon (polytetrafluoroethylene) with > 1 mm ID and < 875 mm in length
» accessory devices that are normally connected to a flexible endoscope during use
» flexible endoscopes without lumens
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222440: Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222440
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026