510(k) · Cleared
ClearedSignia sterilization tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Sep 7, 2016 as substantially equivalent to K130532 (Covidien, Formerly US Surgical A Divison of Tyco H, 2013) after a 114-day review. Its family tree reaches back 5 generations to 1984. 5 later devices descend from it.
- Decided
- Sep 7, 2016
- Review
- 114 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K844002 (1984). 8 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 4 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 3 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 2 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 1 generation backK130532 Idrive Ultra Sterilization TrayCovidien, Formerly US Surgical A Divison of Tyco H · 2013
- This deviceK161347 Signia sterilization trayCovidien · 2016
- Descendant · cites it directly · 1 of its ownK192781 UroLift System Procedure Kit Sterilization TrayNeotract, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK180915 Sonicision Reusable Sterilization TrayCovidien · 2018
- Descendant · 2 generations on · 0 of its ownK243589 PAL Sterilization CaseMicroaire Surgical Instruments, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK212396 UroLift System Rigid Retrieval Kit Sterilization TrayNeotract, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK170226 iTotal Family Reusable Instrument TrayConformis, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K192781UroLift System Procedure Kit Sterilization TrayNeotract, Inc. · 2020 · cites it directly1descendant
- K180915Sonicision Reusable Sterilization TrayCovidien · 2018 · cites it directly1descendant
- K243589PAL Sterilization CaseMicroaire Surgical Instruments, LLC · 2025 · 2 generations on0descendants
- K212396UroLift System Rigid Retrieval Kit Sterilization TrayNeotract, Inc. · 2021 · 2 generations on0descendants
- K170226iTotal Family Reusable Instrument TrayConformis, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −4 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −3 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −2 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −1 | K130532 | Idrive Ultra Sterilization Tray | Covidien, Formerly US Surgical A Divison of Tyco H | 2013 | — |
| 0 (this device) | K161347 | Signia sterilization tray | Covidien | 2016 | — |
| +1 | K192781 | UroLift System Procedure Kit Sterilization Tray | Neotract, Inc. | 2020 | — |
| +1 | K180915 | Sonicision Reusable Sterilization Tray | Covidien | 2018 | — |
| +2 | K243589 | PAL Sterilization Case | Microaire Surgical Instruments, LLC | 2025 | — |
| +2 | K212396 | UroLift System Rigid Retrieval Kit Sterilization Tray | Neotract, Inc. | 2021 | — |
| +1 | K170226 | iTotal Family Reusable Instrument Tray | Conformis, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K130532 | Idrive Ultra Sterilization TraySummary page 4…l Hospital Common Name: Sterilization tray PREDICATE DEVICE: Proprietary/Trade Name: iDrive™ Ultra sterilization tray 510(k) Number: K130532 (Clearance date: May 20, 2013) Classification Name: Sterilization wrap Regulation Number: 21 CFR 880.6850… | 2013 |
What descends from it? (5)
3 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 32 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K192781 (Neotract, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K130532.
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 Signia™ sterilization tray is intended to provide storage for the Signia™ adapters, Signia™ reusable insertion guide and Signia™ manual retraction tool during sterilization, storage and transportation within the hospital environment. The Signia™ sterilization tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked…
Read the full statement (173 words)
The Signia™ sterilization tray is intended to provide storage for the Signia™ adapters, Signia™ reusable insertion guide and Signia™ manual retraction tool during sterilization, storage and transportation within the hospital environment. The Signia™ sterilization tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration. The tray can contain at a maximum: one (1) Signia™ adapter, one (1) Signia™ reusable insertion guide and one (1) Signia™ manual retraction tool. The tray is intended to allow steam sterilization of the enclosed medical devices. The validated sterilization cycle parameters are as follows:
STEAM STERILIZATION
Pre-vacuum (HiVac) Steam Cycles
Item: Tray with components wrapped or in sterilization container system
132 °C Pre-vacuum (HiVac) Steam Cycles: Exposure temperature 270 °F (132 °C); Exposure time 4 minutes; Vacuum dry time 20 - 40 minutes.
134 °C Pre-vacuum (HiVac) Steam Cycles: Exposure temperature 273 °F (134 °C); Exposure time 3 minutes; Vacuum dry time 20 - 40 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161347: Signia 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/K161347
Report an extraction error
Are you the manufacturer?
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