510(k) · Cleared
ClearedEZ-TRAX Containment Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K1 Medical, LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Dec 23, 2019 as substantially equivalent to K152241 (Medtronic Sofamor Danek USA, Inc., 2016) after a 103-day review. Its family tree reaches back 7 generations to 1984. 3 later devices descend from it.
- Decided
- Dec 23, 2019
- Review
- 103 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. 3 later devices descend 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 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 deviceK192487 EZ-TRAX Containment DeviceK1 Medical, LLC · 2019
- Descendant · cites it directly · 2 of its ownK202270 EZ-TRAX Stryker Mako Total Knee with Triathlon Containment DeviceK1 Medical, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK211007 EZ-TRAXTM Persona Knee Containment DeviceK1 Medical, LLC · 2021
- Descendant · 3 generations on · 0 of its ownK213209 EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System…K1 Medical, LLC · 2021
Most influential descendants
Showing 3 of 3 · See all- K202270EZ-TRAX Stryker Mako Total Knee with Triathlon Containment DeviceK1 Medical, LLC · 2020 · cites it directly2descendants
- K211007EZ-TRAXTM Persona Knee Containment DeviceK1 Medical, LLC · 2021 · 2 generations on1descendant
- K213209EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment DeviceK1 Medical, LLC · 2021 · 3 generations on0descendants
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) | K192487 | EZ-TRAX Containment Device | K1 Medical, LLC | 2019 | — |
| +1 | K202270 | EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device | K1 Medical, LLC | 2020 | — |
| +2 | K211007 | EZ-TRAXTM Persona Knee Containment Device | K1 Medical, LLC | 2021 | — |
| +3 | K213209 | EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment… | K1 Medical, LLC | 2021 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 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…ssification Name: Sterilization Wrap Regulatory Class: Class II, 21 CFR 880.6850 Product Code: KCT Predicate Device: Medtronic Transportation / Sterilization Cassettes (K152241) Intended Use / Indications for Use The EZ-TRAX™ Containment Device is intended for use as an accessory in healthcare facilities… | 2016 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202270 | EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device | 2020 | 2 |
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 8 companies; a new generation was cleared every 3.3 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K202270 (K1 Medical, LLC, 2020) has gone furthest, with 2 descendants of its own.
- 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 EZ-TRAX™ Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store medical devices between surgical and other medical uses. The EZ-TRAX™ Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system. Validated Cycle Times for Dynamic Air Removal Steam…
Read the full statement (203 words)
The EZ-TRAX™ Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store medical devices between surgical and other medical uses. The EZ-TRAX™ Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.
Validated Cycle Times for Dynamic Air Removal Steam Sterilization Cycles
Cycle Temperature Exposure Time Drying Time
Dynamic Air 10 minutes
270° F/ 132° C 4 minutes
Removal
Sterilization validations included a worst case EZ-TRAX™ Containment Device and a medical device challenge set comprising of:
- Lumen dimensions (3) 1mm x 500mm
- Conjoined/mated surfaces: forceps, clamps, bending pliers, ratchet handles, retractors
- Cannulated: drill bits, taps, guides, screwdrivers, cannulated screws
- A total weight of 42 lbs comprising of (EZ-TRAX™ Containment Device + sterile barrier system + medical device load) as a worst case challenge to the system. Healthcare facilities should not exceed 25 pounds (EZ-TRAX™ Containment Device + sterile barrier system + medical device load).
The EZ-TRAX™ is offered in the following sizes:
Brand Name Model Dimensions
EZ-TRAX™ BASE.ASSY.AL.24.12.2 (L) 22.97” (W) 11.18” (H) 2.04”
EZ-TRAX™ BASE.ASSY.AL.24.12.2.4 (L) 22.97” (W) 11.18” (H) 2.44”
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192487 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192487: EZ-TRAX Containment Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192487
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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