510(k) · Cleared
ClearedUroLift System Rigid Retrieval Kit Sterilization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neotract, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Oct 22, 2021 as substantially equivalent to K192781 (Neotract, Inc., 2020) after an 81-day review. Its family tree reaches back 7 generations to 1984.
- Decided
- Oct 22, 2021
- Review
- 81 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K844002 (1984). 10 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 backK130532 Idrive Ultra Sterilization TrayCovidien, Formerly US Surgical A Divison of Tyco H · 2013
- 2 generations backK161347 Signia sterilization trayCovidien · 2016
- 1 generation backK192781 UroLift System Procedure Kit Sterilization TrayNeotract, Inc. · 2020
- This deviceK212396 UroLift System Rigid Retrieval Kit Sterilization TrayNeotract, Inc. · 2021
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 | K130532 | Idrive Ultra Sterilization Tray | Covidien, Formerly US Surgical A Divison of Tyco H | 2013 | — |
| −2 | K161347 | Signia sterilization tray | Covidien | 2016 | — |
| −1 | K192781 | UroLift System Procedure Kit Sterilization Tray | Neotract, Inc. | 2020 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K192781 | UroLift System Procedure Kit Sterilization TraySummary page 5…n contraindications. PREDICATE DEVICE The predicate device is the UroLift System Procedure Kit Sterilization Tray, NeoTract / Teleflex (K192781). Trade Name: UroLift System Procedure Kit Sterilization Tray (UL-PKTRAY) Common Name: Steri… | 2020 |
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 37 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- None of the 10 ancestors has a recall.
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. 2021, 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 UroLift System Rigid Retrieval Kit Sterilization Tray is intended to be used to enclose and protect surgical instruments optionally used for the UroLift System procedure for storage and sterilization in a prevacuum steam sterilizer. The following instruments are intended to be loaded into the UroLift System Rigid Retrieval Kit Sterilization Tray: • UL-SCOPE4-0 / UL-SCOPE4-0-FE* – Cystoscope, 4.0 mm diameter x 302 mm length, 0° angle of view, wide…
Read the full statement (168 words)
The UroLift System Rigid Retrieval Kit Sterilization Tray is intended to be used to enclose and protect surgical instruments optionally used for the UroLift System procedure for storage and sterilization in a prevacuum steam sterilizer. The following instruments are intended to be loaded into the UroLift System Rigid Retrieval Kit Sterilization Tray:
• UL-SCOPE4-0 / UL-SCOPE4-0-FE* – Cystoscope, 4.0 mm diameter x 302 mm length, 0° angle of view, wide angle
• UL-GRASP-R – Optical Graspers, double action jaws
• UL-SCI-R – Optical Scissors, double action jaws
* Factory Exchange: Devices with a part number ending in “FE” have been repaired to meet product specifications.
The tray by itself is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, 510(k) cleared sterilization wrap to maintain sterility of the enclosed instruments when sterilized using the following prevacuum steam sterilization cycles:
Prevacuum Steam
Temperature: 132°C (270°F)
Sterilization time: 4 minutes
Minimum dry time: 30 minutes
Maximum weight: 5 lbs (2.7 kg)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212396: UroLift System Rigid Retrieval Kit 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/K212396
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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