510(k) · Cleared
ClearedUroLift System Procedure 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 Apr 14, 2020 as substantially equivalent to K161347 (Covidien, 2016) after a 197-day review. Its family tree reaches back 6 generations to 1984. 1 later device descends from it.
- Decided
- Apr 14, 2020
- Review
- 197 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K844002 (1984). 9 ancestors in all. 1 later device descends from it, 1 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 backK130532 Idrive Ultra Sterilization TrayCovidien, Formerly US Surgical A Divison of Tyco H · 2013
- 1 generation backK161347 Signia sterilization trayCovidien · 2016
- This deviceK192781 UroLift System Procedure Kit Sterilization TrayNeotract, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK212396 UroLift System Rigid Retrieval Kit Sterilization TrayNeotract, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K212396UroLift System Rigid Retrieval Kit Sterilization TrayNeotract, Inc. · 2021 · cites it directly0descendants
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 | K130532 | Idrive Ultra Sterilization Tray | Covidien, Formerly US Surgical A Divison of Tyco H | 2013 | — |
| −1 | K161347 | Signia sterilization tray | Covidien | 2016 | — |
| 0 (this device) | K192781 | UroLift System Procedure Kit Sterilization Tray | Neotract, Inc. | 2020 | — |
| +1 | 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 |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K161347 | Signia sterilization traySummary page 6…tions. PREDICATE DEVICE The predicate device is the SigniaTM Sterilization Tray from Medtronic® (formerly Covidien®) (K161347). Trade Name: Signia Sterilization Tray Common Name: Sterilization Wrap Co… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212396 | UroLift System Rigid Retrieval Kit Sterilization Tray | 2021 | 0 |
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 36 years and passes through 7 companies; a new generation was cleared every 3.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K212396 (Neotract, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K161347.
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. 2020, 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 Procedure Kit Sterilization Tray is intended to be used to enclose and protect surgical instruments used for the UroLift System Procedure for storage and sterilization in a pre-vacuum steam sterilizer. The following instruments are intended to be loaded into the UroLift System Procedure Kit Sterilization Tray: • UL-SCOPE / UL-SCOPE-FE – Cystoscope, 2.9 mm diameter x 365 mm length, 0° angle of view, 85° field of view • UL-SHEATH /…
Read the full statement (191 words)
The UroLift System Procedure Kit Sterilization Tray is intended to be used to enclose and protect surgical instruments
used for the UroLift System Procedure for storage and sterilization in a pre-vacuum steam sterilizer.
The following instruments are intended to be loaded into the UroLift System Procedure Kit Sterilization Tray:
• UL-SCOPE / UL-SCOPE-FE – Cystoscope, 2.9 mm diameter x 365 mm length, 0° angle of view, 85° field of view
• UL-SHEATH / UL-SHEATH-FE – Sheath, 20 Fr., with 2 tube connectors (Luer lock and Luer lock with stopcock)
• UL-VO / UL-VO-FE – Visual obturator, 20 Fr.
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 pre-vacuum steam sterilization cycles:
132 °C Pre-vacuum Steam Cycle
Exposure temperature: 270 °F (132 °C)
Exposure time: 4 minutes
Vacuum dry time: 30 minutes
134 °C Pre-vacuum Steam Cycle
Exposure temperature: 273 °F (134 °C)
Exposure time: 3 minutes
Vacuum dry time: 20 minutes
The maximum weight of the tray is 1.8kg / 4lbs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192781: UroLift System Procedure 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/K192781
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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