510(k) · Cleared
ClearedPRO-LITE Sterilization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Mar 1, 2019 as substantially equivalent to K172755 (STERIS Corporation, 2018) after an 84-day review. Its family tree reaches back 10 generations to 1984. 3 later devices descend from it.
- Decided
- Mar 1, 2019
- Review
- 84 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K844002 (1984). 16 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 6 generations between
- 3 generations backK140494 V-Pro Sterilization Tray/ Sterilization MatSTERIS Corporation · 2014
- 2 generations backK160912 Sterilization TraySTERIS Corporation · 2016
- 1 generation backK172755 PRO-LITE Sterilization TraysSTERIS Corporation · 2018
- This deviceK183402 PRO-LITE Sterilization TraySTERIS Corporation · 2019
- Descendant · cites it directly · 2 of its ownK222440 Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE…Steris · 2022
- Descendant · 2 generations on · 0 of its ownK231501 PRO-LITE Sterilization TraySTERIS Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK231500 Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation · 2023
Show all 10 generations
- Root · 10 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 9 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 8 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 7 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 6 generations backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- 5 generations backK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- 4 generations backK070769 VHP 136 TraySTERIS Corporation · 2007
- 3 generations backK140494 V-Pro Sterilization Tray/ Sterilization MatSTERIS Corporation · 2014
- 2 generations backK160912 Sterilization TraySTERIS Corporation · 2016
- 1 generation backK172755 PRO-LITE Sterilization TraysSTERIS Corporation · 2018
- This deviceK183402 PRO-LITE Sterilization TraySTERIS Corporation · 2019
Most influential descendants
Showing 3 of 3 · See all- K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSteris · 2022 · cites it directly2descendants
- K231501PRO-LITE Sterilization TraySTERIS Corporation · 2023 · 2 generations on0descendants
- K231500Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −9 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −8 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −7 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −6 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| −5 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| −4 | K070769 | VHP 136 Tray | STERIS Corporation | 2007 | — |
| −3 | K140494 | V-Pro Sterilization Tray/ Sterilization Mat | STERIS Corporation | 2014 | — |
| −2 | K160912 | Sterilization Tray | STERIS Corporation | 2016 | — |
| −1 | K172755 | PRO-LITE Sterilization Trays | STERIS Corporation | 2018 | — |
| 0 (this device) | K183402 | PRO-LITE Sterilization Tray | STERIS Corporation | 2019 | — |
| +1 | K222440 | Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization… | Steris | 2022 | — |
| +2 | K231501 | PRO-LITE Sterilization Tray | STERIS Corporation | 2023 | — |
| +2 | K231500 | Vis-U-All Low Temperature Sterilization Pouches | STERIS Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 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 KCT? 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 KCT device
- #1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K172755 | PRO-LITE Sterilization TraysSummary page 8…21 CFR 880.6850 Class II Product Code KCT 2. Predicate Device PRO-LITE Sterilization Tray, K172755 Reference Device: PRO-LITE Sterilization Tray, K183301 3. Description of Device The PRO-LITE Sterilization Trays… | 2018 |
| † | K183301 | PRO-LITE Sterilization Tray | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222440 | Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays | 2022 | 2 |
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 35 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K222440 (Steris, 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K172755.
How does its category compare?
All KCT devicesKCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KCT
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KCT
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KCT
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCT
50in 2025
MAUDE reports naming product code KCT, 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 | 199 | 0 | 2 |
| 2008 | 6 | 182 | 0 | 8 |
| 2009 | 6 | 89 | 0 | 5 |
| 2010 | 12 | 202 | 1 | 3 |
| 2011 | 6 | 117 | 2 | 3 |
| 2012 | 10 | 236 | 0 | 2 |
| 2013 | 8 | 131 | 1 | 6 |
| 2014 | 11 | 169 | 1 | 5 |
| 2015 | 15 | 151 | 0 | 6 |
| 2016 | 12 | 182 | 3 | 16 |
| 2017 | 10 | 211 | 1 | 3 |
| 2018 | 15 | 192 | 0 | 22 |
| 2019 | 18 | 187 | 0 | 15 |
| 2020 | 14 | 134 | 0 | 66 |
| 2021 | 18 | 185 | 1 | 26 |
| 2022 | 11 | 137 | 17 | 8 |
| 2023 | 10 | 94 | 0 | 30 |
| 2024 | 8 | 106 | 0 | 18 |
| 2025 | 11 | 205 | 0 | 50 |
| 2026 | 9 | 122 | 0 | — |
What is it indicated for?
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, DUO Cycles of the STERRAD 100NX and 100NX with ALLClear…
Read the full statement (1,492 words)
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, 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, VP0050, VP0051, VP0052
V-PRO 60 & s2 Lumen Cycle
• Instruments 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:
• single or dual lumen devices
• ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length
• 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 dimensions:
• ≥ 2 mm ID and ≤ 400 mm in length
• ≥ 0.76 mm ID and ≤ 233 mm in length
• ≥ 1.0 mm ID and ≤ 254 mm in length
Intended Sterilization Cycles 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 or scissors.
• Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:
• Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm ID and ≤ 410 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
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0050, VP0051, VP0052, VP0053
V-PRO 1, 1 Plus, maX & maX 2 Lumen Cycle
• Instruments 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:
• single or dual lumen devices
• ≥ 0.77 mm internal diameter (ID) and ≤ 527 mm in length
• 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 1 Plus, maX & maX 2 Non Lumen Cycle
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors
V-PRO maX & 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 lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
• or two lumens with:
• one lumen that is ≥ 1 mm ID and < 990 mm in length
• and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length
Load 2: Non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors.
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 stainless steel or titanium 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 non-metal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
• Metal and non metal 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 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
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP046, VP0047, VP0048, VP0049, VP0051, VP0052, VP0053
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:
• 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 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
Instrument organizers are optional accessories intended to stabilize cylindrical medical instruments within the Sterilization Trays.
Model Description
VP0054 Blank, Tall
VP0055 Blank, Short
VP0063 3 mm – 7 mm, Tall
VP0064 7 mm – 11 mm, Tall
VP0065 11 mm – 15 mm, Tall
VP0066 15 mm – 19 mm, Tall
VP0067 3 mm – 7 mm, Short
VP0068 7 mm – 11 mm, Short
VP0069 11 mm – 15 mm, Short
VP0070 15 mm – 19 mm, Short
Sterilization mats are optional accessories intended to cushion and stabilize instruments within the Sterilization Trays.
Model Description (to fit Length” x Width” Tray)
VP0071 13 x 4.5
VP0072 19 x 4.5
VP0073 25 x 4.5
VP0074 13 x 7.75
VP0075 19 x 7.75
VP0076 27 x 7.75
VP0077 12 x 11.75
VP0078 25 x 11.75
VP0079 25 x 14
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183402: PRO-LITE Sterilization Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183402
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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