510(k) · Cleared
ClearedSterilization 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 Oct 7, 2016 as substantially equivalent to K140494 (STERIS Corporation, 2014) after a 189-day review. Its family tree reaches back 8 generations to 1984. 6 later devices descend from it.
- Decided
- Oct 7, 2016
- Review
- 189 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K844002 (1984). 14 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 7 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 6 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 5 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 4 generations backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- 3 generations backK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- 2 generations backK070769 VHP 136 TraySTERIS Corporation · 2007
- 1 generation backK140494 V-Pro Sterilization Tray/ Sterilization MatSTERIS Corporation · 2014
- This deviceK160912 Sterilization TraySTERIS Corporation · 2016
- Descendant · cites it directly · 5 of its ownK172755 PRO-LITE Sterilization TraysSTERIS Corporation · 2018
- Descendant · 2 generations on · 3 of its ownK183402 PRO-LITE Sterilization TraySTERIS Corporation · 2019
- Descendant · 3 generations on · 2 of its ownK222440 Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE…Steris · 2022
- Descendant · 4 generations on · 0 of its ownK231501 PRO-LITE Sterilization TraySTERIS Corporation · 2023
- Descendant · 4 generations on · 0 of its ownK231500 Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172755PRO-LITE Sterilization TraysSTERIS Corporation · 2018 · cites it directly5descendants
- K183402PRO-LITE Sterilization TraySTERIS Corporation · 2019 · 2 generations on3descendants
- K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSteris · 2022 · 3 generations on2descendants
- K231501PRO-LITE Sterilization TraySTERIS Corporation · 2023 · 4 generations on0descendants
- K231500Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −7 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −6 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −5 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −4 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| −3 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| −2 | K070769 | VHP 136 Tray | STERIS Corporation | 2007 | — |
| −1 | K140494 | V-Pro Sterilization Tray/ Sterilization Mat | STERIS Corporation | 2014 | — |
| 0 (this device) | K160912 | Sterilization Tray | STERIS Corporation | 2016 | — |
| +1 | K172755 | PRO-LITE Sterilization Trays | STERIS Corporation | 2018 | — |
| +2 | K183402 | PRO-LITE Sterilization Tray | STERIS Corporation | 2019 | — |
| +3 | K222440 | Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization… | Steris | 2022 | — |
| +4 | K231501 | PRO-LITE Sterilization Tray | STERIS Corporation | 2023 | — |
| +4 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K140494 | V-Pro Sterilization Tray/ Sterilization MatSummary page 6…1 CFR 880.6850 Class II Product Code KCT 2. Predicate Device V-PRO Sterilization Tray K140494 3. Description of Device The Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temper… | 2014 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172755 | PRO-LITE Sterilization Trays | 2018 | 5 |
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 32 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K172755 (STERIS Corporation, 2018) has gone furthest, with 5 descendants of its own.
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. 2016, 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 Sterilization Trays are used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible 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 V-PRO Low Temperature Sterilization Systems or placed inside a legally marketed pouch for enclosing trays in the V-PRO Low Temperature Sterilization…
Read the full statement (576 words)
The Sterilization Trays are used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible 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 V-PRO Low Temperature Sterilization Systems
or
placed inside a legally marketed pouch for enclosing trays in the V-PRO Low Temperature Sterilization Systems.
The 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.
Model Number (size LxWxH in inches) Intended Sterilization Cycles Intended Tray Load
VP0045 (13x4.5x2.25), VP0046 (19x4.5x2.25), VP0047 (25x4.5x2.25), VP0048 (13x7.75x2.25), VP0049 (19x7.75x2.25), VP0050 (27x7.75x4), VP0051 (12x11.75x4), VP0052 (25x11,75x4.5), VP0053 (25x14x5)
V-PRO 60 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 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 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 60 Flexible Cycle: 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.
V-PRO 1, 1 Plus & maX 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 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 Non Lumen Cycle: Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors.
V-PRO maX 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.
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/K160912 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160912: Sterilization Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160912
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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