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 Jan 3, 2019 as substantially equivalent to K172755 (STERIS Corporation, 2018) after a 37-day review. Its family tree reaches back 10 generations to 1984.
- Decided
- Jan 3, 2019
- Review
- 37 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. No later device cites it as a predicate yet.
- 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 deviceK183301 PRO-LITE Sterilization TraySTERIS Corporation · 2019
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 deviceK183301 PRO-LITE Sterilization TraySTERIS Corporation · 2019
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) | K183301 | PRO-LITE Sterilization Tray | STERIS Corporation | 2019 | — |
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 |
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 7…21 CFR 880.6850 Class II Product Code KCT 2. Predicate Device PRO-LITE Sterilization Tray, K172755 3. Description of Device The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO L… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 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 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…
Read the full statement (879 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
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 ≤ 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 1, 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 1, 1 Plus, 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 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.
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.
Instrument organizers are optional accessories intended to stabilize cylindrical medical instruments within the Sterilization Trays.
Sterilization mats are optional accessories intended to cushion and stabilize instruments within the Sterilization Trays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183301: 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/K183301
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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