510(k) · Cleared
ClearedMedtronic Transportation/Sterilization Cassettes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jan 20, 2016 as substantially equivalent to K131455 (Restore Medical Solutions, Inc., 2013) and 3 other predicates after a 163-day review. Its family tree reaches back 6 generations to 1984. 29 later devices descend from it.
- Decided
- Jan 20, 2016
- Review
- 163 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K844002 (1984). 12 ancestors in all. 29 later devices descend from it, 4 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 backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 1 generation backK120947 THS Instrument TrayHologic, Inc. · 2012
- This deviceK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- Descendant · cites it directly · 18 of its ownK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- Descendant · 2 generations on · 11 of its ownK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- Descendant · 3 generations on · 5 of its ownK212281 Surgical TraysDentsply Sirona, Inc. · 2022
- Descendant · 2 generations on · 5 of its ownK181075 PureSet TrayNobel Biocare AB · 2018
- Descendant · 3 generations on · 4 of its ownK191475 Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate…Nobel Biocare AB · 2019
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K163600Kit Boxes and Kit PlatesNobel Biocare AB · 2018 · cites it directly18descendants
- K180791Straumann BLX Surgical CassetteInstitut Straumann AG · 2018 · 2 generations on11descendants
- K212281Surgical TraysDentsply Sirona, Inc. · 2022 · 3 generations on5descendants
- K181075PureSet TrayNobel Biocare AB · 2018 · 2 generations on5descendants
- K191475Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray…Nobel Biocare AB · 2019 · 3 generations on4descendants
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 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −1 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| 0 (this device) | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| +1 | K163600 | Kit Boxes and Kit Plates | Nobel Biocare AB | 2018 | — |
| +2 | K180791 | Straumann BLX Surgical Cassette | Institut Straumann AG | 2018 | — |
| +3 | K212281 | Surgical Trays | Dentsply Sirona, Inc. | 2022 | — |
| +2 | K181075 | PureSet Tray | Nobel Biocare AB | 2018 | — |
| +3 | K191475 | Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic… | Nobel Biocare AB | 2019 | — |
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 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K131455 | Restore Modular Sterilization Tray SystemSummary page 5…0) Class: II Product Code: KCT III. Predicate Devices: • K131455 (Primary Predicate) – Restore Modular Sterilization Tray… | 2013 |
| * | K033222 | Olympus Sterilization TraysSummary page 5…Restore Modular Sterilization Tray System (S.E. 08/30/2013) • K033222 – Olympus Sterilization Trays (S.E. 08/02/2004) • K99… | 2004 |
| * | K993535 | Metapak Multi-Purpose Instrument TraySummary page 5…• K033222 – Olympus Sterilization Trays (S.E. 08/02/2004) • K993535 – Metapak Multi-Purpose Instrument Tray (S.E. 12/07/2001)… | 2001 |
| * | K120947 | THS Instrument TraySummary page 5…• K993535 – Metapak Multi-Purpose Instrument Tray (S.E. 12/07/2001) • K120947 – THS Sterilization Tray (S.E. 10/17/2012) Additionally, this submission contains a refe… | 2012 |
| † | K130720 | Synthes Reusable Sterilization Container System | 2014 |
What descends from it? (29)
See all 294 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 7 companies; a new generation was cleared every 3.3 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K163600 (Nobel Biocare AB, 2018) has gone furthest, with 18 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 Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap.…
Read the full statement (273 words)
The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap.
Sterilization validations for the worst case Medtronic Transportation/Sterilization Cassette (22.75 x 11.26 x 5.5 inches) included implants and common surgical instruments such as rasps, drivers, trials, handles, inserters, probes, drills, etc. The validated total weight was 28.4lbs. The validated worst case loading configurations of the Medtronic Transportation/Sterilization Cassette included the following worst case lumen dimensions.
- 363 x 1.575mm
- 247.5 x 4.1mm
Device List:
1850060 Case - Triple Generic Outer Base (22.74 x 11.260 x 5.040 inches)
1850064 Lid - Generic Outer Lid (22.75 x 11.260 x 0.470 inches)
7022101L Tray Lid (21 x 10.13 x 0.075 inches)
P1850061 Tray 1 (20.75 x 9.79 x 1.32 inches)
P1850062 Tray 2 (21 x 10.13 x 1.69 inches)
P1850063 Tray 3 (21 x 10.13 x 1.38 inches)
7059532 Large Caddy (9.47 x 6.37 x 1.3 inches)
7059532L Large Lid (5.85 x 4.725 x 0.095 inches)
P9213018 Small Caddy (2 x 1.5 x 1.025 inches)
P9213018 Small Lid (2 x 1.29 x 0.095 inches)
Sterilization Parameters:
Cycle Temperature Exposure time Minimum dry time
Gravity Displacement 250°F (121°C) 30 Minutes 30 Minutes
Gravity Displacement 270°F (132°C) 15 Minutes 30 Minutes
Gravity Displacement 275°F (135°C) 10 Minutes 30 Minutes
Dynamic-Air-Removal
(4 Pre-conditioning pulses) 270°F (132°C) 4 Minutes 30 Minutes
Dynamic-Air-Removal
(4 Pre-conditioning pulses) 275°F (135°C) 3 Minutes 30 Minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152241: Medtronic Transportation/Sterilization Cassettes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152241
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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