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 Oct 15, 2019 as substantially equivalent to K152241 (Medtronic Sofamor Danek USA, Inc., 2016) after a 197-day review. Its family tree reaches back 7 generations to 1984.
- Decided
- Oct 15, 2019
- Review
- 197 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K844002 (1984). 13 ancestors in all. No later device cites it as a predicate yet.
- 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 backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 2 generations backK120947 THS Instrument TrayHologic, Inc. · 2012
- 1 generation backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- This deviceK190840 Medtronic Transportation / Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2019
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 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −2 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| −1 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| 0 (this device) | K190840 | Medtronic Transportation / Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 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 |
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 |
|---|---|---|---|
| * | K152241 | Medtronic Transportation/Sterilization CassettesSummary page 5…Cassettes & Other Accessories (21 CFR 880.6850) Name Classification Class II Product Codes KCT Predicate Medtronic Transportation /Sterilization Cassettes (K152241, S.E. 1/20/2016) Device Description of The Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddie… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- None of the 13 ancestors has a recall.
- 3 other devices also cite its predicate K152241.
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. 2019, 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; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The…
Read the full statement (230 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; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation Sterilization Cassettes are intended for transport of non-sterile loads.
Sterilization validations for the worst case Medtronic Transportation/Sterilization Cassettes (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 28.6lbs. The validated worst case loading configurations of the Medtronic Transportation/Sterilization Cassettes included the following worst case lumen dimensions:
• 363 x 1.575mm
• 247.5 x 4.1mm
Device list:
• P l 850078 Generic Triple Outer Base (22.74x1l.26x5.04 inches)
• P1850079 Generic Outer Lid (22.75xl l.26x.470 inches)
• 7022101L Tray Lid (21.00x10.13x.075 inches)
• P1850010 Tray 1 (20.7Ix9.82x4.4 inches)
• P1850011 Tray 2 (18.8Ix9.50x2.8 inches)
• P1850012 Tray 3 (18.30x9.20x.840 inches)
• P1850013 Large Caddy (9.4x5.Jxl.49 inches)
• P1850014 Large Lid (9.40x5.045x.095 inches)
• P1850015 Small Caddy (2.00x l .50x1.025 inches)
• P1850016 Small Lid (2.0xl.245x.095 inches)
Sterilization Parameters
Cycle Temperature Exposure time Minimum dry time
Dynamic-air-removal 270° F (132° C) 4 Minutes 30 Minutes
Dynamic-air-removal 275° F (135° C) 3 Minutes 30 Minutes
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/K190840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190840: 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/K190840
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