510(k) · Cleared
ClearedIdrive Ultra Sterilization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, Formerly US Surgical A Divison of Tyco H · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on May 30, 2013 as substantially equivalent to K012105 (Symmetry Medical, Inc., 2002) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1984. 6 later devices descend from it.
- Decided
- May 30, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K844002 (1984). 7 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 3 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 2 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 1 generation backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- This deviceK130532 Idrive Ultra Sterilization TrayCovidien, Formerly US Surgical A Divison of Tyco H · 2013
- Descendant · cites it directly · 5 of its ownK161347 Signia sterilization trayCovidien · 2016
- Descendant · 2 generations on · 1 of its ownK192781 UroLift System Procedure Kit Sterilization TrayNeotract, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK180915 Sonicision Reusable Sterilization TrayCovidien · 2018
- Descendant · 3 generations on · 0 of its ownK243589 PAL Sterilization CaseMicroaire Surgical Instruments, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK212396 UroLift System Rigid Retrieval Kit Sterilization TrayNeotract, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161347Signia sterilization trayCovidien · 2016 · cites it directly5descendants
- K192781UroLift System Procedure Kit Sterilization TrayNeotract, Inc. · 2020 · 2 generations on1descendant
- K180915Sonicision Reusable Sterilization TrayCovidien · 2018 · 2 generations on1descendant
- K243589PAL Sterilization CaseMicroaire Surgical Instruments, LLC · 2025 · 3 generations on0descendants
- K212396UroLift System Rigid Retrieval Kit Sterilization TrayNeotract, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −3 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −2 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −1 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| 0 (this device) | K130532 | Idrive Ultra Sterilization Tray | Covidien, Formerly US Surgical A Divison of Tyco H | 2013 | — |
| +1 | K161347 | Signia sterilization tray | Covidien | 2016 | — |
| +2 | K192781 | UroLift System Procedure Kit Sterilization Tray | Neotract, Inc. | 2020 | — |
| +2 | K180915 | Sonicision Reusable Sterilization Tray | Covidien | 2018 | — |
| +3 | K243589 | PAL Sterilization Case | Microaire Surgical Instruments, LLC | 2025 | — |
| +3 | K212396 | UroLift System Rigid Retrieval Kit Sterilization Tray | Neotract, Inc. | 2021 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K012105 | Polyvac Surgical Instrument Delivery SystemSummary page 1….6850 COMMON/USUAL NAME: sterilization tray CLASSIFICATION NAME: sterilization wrap PREDICATE DEVICES: PolyVac Surgical Instrument Delivery System (K012105) MetaPak Multi-Purpose Instrument Tray (K993535) DEVICE DESCRIPTION: The iDriveTM Ultra steriliz… | 2002 |
| * | K993535 | Metapak Multi-Purpose Instrument TraySummary page 1…sterilization wrap PREDICATE DEVICES: PolyVac Surgical Instrument Delivery System (K012105) MetaPak Multi-Purpose Instrument Tray (K993535) DEVICE DESCRIPTION: The iDriveTM Ultra sterilization tray is an optional, over-the - counter, a… | 2001 |
What descends from it? (6)
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 29 years and passes through 5 companies; a new generation was cleared every 10.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K161347 (Covidien, 2016) has gone furthest, with 5 descendants of its own.
- 20 other devices also cite its predicate K012105.
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 iDrive™ Ultra sterilization tray (IDRVTRAY) is intended to provide storage for the iDrive™ Ultra powered stapling system during sterilization, storage and transportation within the hospital environment. The iDrive™ Ultra 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…
Read the full statement (121 words)
The iDrive™ Ultra sterilization tray (IDRVTRAY) is intended to provide storage for the iDrive™ Ultra powered stapling system during sterilization, storage and transportation within the hospital environment. The iDrive™ Ultra 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) iDrive™ Ultra powered handle, two (2) Endo GIA™ adapters, two (2) iDrive™ battery insertion guides and one (1) iDrive™ Ultra manual adapter tool. The tray is intended to be sterilized by the following cycles:
Prevacuum Steam Cycles
132°C for 4 minutes
134°C for 3 minutes
Vacuum Dry: 20 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130532 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130532: Idrive Ultra 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/K130532
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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