510(k) · Cleared
ClearedVHP 136 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 5, 2007 as substantially equivalent to K052992 (Conmed Linvatec, 2006) and 2 other predicates after a 199-day review. Its family tree reaches back 6 generations to 1984. 10 later devices descend from it.
- Decided
- Oct 5, 2007
- Review
- 199 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K844002 (1984). 11 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 4 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 3 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 2 generations backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- 1 generation backK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- This deviceK070769 VHP 136 TraySTERIS Corporation · 2007
- Descendant · cites it directly · 7 of its ownK140494 V-Pro Sterilization Tray/ Sterilization MatSTERIS Corporation · 2014
- Descendant · 2 generations on · 6 of its ownK160912 Sterilization TraySTERIS Corporation · 2016
- Descendant · 3 generations on · 5 of its ownK172755 PRO-LITE Sterilization TraysSTERIS Corporation · 2018
- Descendant · 4 generations on · 3 of its ownK183402 PRO-LITE Sterilization TraySTERIS Corporation · 2019
- Descendant · 5 generations on · 2 of its ownK222440 Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE…Steris · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K140494V-Pro Sterilization Tray/ Sterilization MatSTERIS Corporation · 2014 · cites it directly7descendants
- K160912Sterilization TraySTERIS Corporation · 2016 · 2 generations on6descendants
- K172755PRO-LITE Sterilization TraysSTERIS Corporation · 2018 · 3 generations on5descendants
- K183402PRO-LITE Sterilization TraySTERIS Corporation · 2019 · 4 generations on3descendants
- K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSteris · 2022 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −5 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −4 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −3 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −2 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| −1 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| 0 (this device) | K070769 | VHP 136 Tray | STERIS Corporation | 2007 | — |
| +1 | K140494 | V-Pro Sterilization Tray/ Sterilization Mat | STERIS Corporation | 2014 | — |
| +2 | K160912 | Sterilization Tray | STERIS Corporation | 2016 | — |
| +3 | K172755 | PRO-LITE Sterilization Trays | STERIS Corporation | 2018 | — |
| +4 | K183402 | PRO-LITE Sterilization Tray | STERIS Corporation | 2019 | — |
| +5 | K222440 | Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization… | Steris | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K052992 | Conmed Linvatec Instrument Sterilization TraySummary page 2…Instrument Sterilization Trays Instrument Sterilization Tray Tray Kg K052992 K033222 K013003 SE Date 10/16/06 08/02/04 08/28/… | 2006 |
| * | K033222 | Olympus Sterilization TraysSummary page 2…erilization Trays Instrument Sterilization Tray Tray Kg K052992 K033222 K013003 SE Date 10/16/06 08/02/04 08/28/02 STERIS Corporat… | 2004 |
| * | K013003 | Aptimax Instrument Tray, Instrument Mat and Instrument HolderSummary page 2…Instrument Sterilization Tray Tray Kg K052992 K033222 K013003 SE Date 10/16/06 08/02/04 08/28/02 STERIS Corporation performed qualifica… | 2002 |
| † | K062297 | VHP 136 Low Temperature Sterilization System | 2007 |
What descends from it? (10)
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 23 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K140494 (STERIS Corporation, 2014) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K052992.
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. 2007, 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 V-PRO TM Sterilization Tray is used to contain devices for sterilization in the Amsco® V-PRO TM 1 Low Temperature Sterilizer and to maintain sterility of properly processed medical devices during normal handling and storage until they are removed for use. The trays must be wrapped with a legally marketed, FDA cleared sterilization wrap for use in the Amsco® V-PROTM I Low Temperature Sterilizer prior to placing in the Sterilizer. The V-PRO TM…
Read the full statement (108 words)
The V-PRO TM Sterilization Tray is used to contain devices for sterilization in the Amsco® V-PRO TM 1 Low Temperature Sterilizer and to maintain sterility of properly processed medical devices during normal handling and storage until they are removed for use. The trays must be wrapped with a legally marketed, FDA cleared sterilization wrap for use in the Amsco® V-PROTM I Low Temperature Sterilizer prior to placing in the Sterilizer.
The V-PRO TM Sterilization Tray can be used with V-PRO TM Instrument Organizers to allow stabilization of various cylindrical medical devices during processing. The Instrument Organizers attach to the V-PROTM Sterilization Tray bottom and stabilize cylindrical medical instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070769 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070769: VHP 136 Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070769
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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