510(k) · Cleared
ClearedSonicision Sterilization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, Formerly Valleylab, A Division of Tyco H · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Aug 28, 2013 as substantially equivalent to K112536 (Covidien, 2012) and 2 other predicates after a 126-day review. Its family tree reaches back 7 generations to 1984. 1 later device descends from it.
- Decided
- Aug 28, 2013
- Review
- 126 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K844002 (1984). 15 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 6 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 5 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 4 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 3 generations backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- 2 generations backK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- 1 generation backK070769 VHP 136 TraySTERIS Corporation · 2007
- This deviceK131170 Sonicision Sterilization TrayCovidien, Formerly Valleylab, A Division of Tyco H · 2013
- Descendant · cites it directly · 0 of its ownK151347 MIS Spine Frame Instrument CaseThompson Surgical Instruments · 2015
Most influential descendants
Showing 1 of 1 · See all- K151347MIS Spine Frame Instrument CaseThompson Surgical Instruments · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −6 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −5 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −4 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −3 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| −2 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| −1 | K070769 | VHP 136 Tray | STERIS Corporation | 2007 | — |
| 0 (this device) | K131170 | Sonicision Sterilization Tray | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| +1 | K151347 | MIS Spine Frame Instrument Case | Thompson Surgical Instruments | 2015 | — |
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 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (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 |
|---|---|---|---|
| * | K112536 | Sonicision Sterilization Tray | 2012 |
| * | K070769 | VHP 136 TraySummary page 1…y 5 10(k) Number: KI 12536, cleared 4/19/2012 Manufacturer: Covidien Trade Name: Sterilization Tray ®-RO 5 10(k) Number: K070769, cleared 10/5/2007 Manufacturer: STERIS Corporation Trade Name: FinESSTM Endoscope Sterilization Tray 5 10(k) Number… | 2007 |
| * | K103213 | Finess Endoscope Sterilization TraySummary page 1…®-RO 5 10(k) Number: K070769, cleared 10/5/2007 Manufacturer: STERIS Corporation Trade Name: FinESSTM Endoscope Sterilization Tray 5 10(k) Number: K 103213, cleared 2/2/2011I Manufacturer: Entellus Medical, Inc. Device Description The SonicisionTM Sterilization Tray is intended t… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151347 | MIS Spine Frame Instrument Case | 2015 | 0 |
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 29 years and passes through 8 companies; a new generation was cleared every 3.1 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K151347 (Thompson Surgical Instruments, 2015) has gone furthest, with 0 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. 2013, 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 Sonicision Sterilization Tray is intended to be used to encase and protect reusable battery packs and generators of the Sonicision system during sterilization and storage. The tray containing up to one generator and one battery pack (maximum load) can be used with the following models and pre-set (non-adjustable) cycles.
STERRAD 100S — Standard
STERRAD NX — Standard
STERRAD 100NX — Standard
STERIS Amsco V-PRO I — Lumen
STERIS Amsco V-PRO I Plus — Lumen
STERIS Amsco V-PRO maX — Lumen
Maintenance of sterility of the content within the tray is based on demonstrated performance of the sterilization wrap or pouch used to encase the tray.
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/K131170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131170: Sonicision 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/K131170
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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