510(k) · Cleared
ClearedTenex 2nd Generation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trice Medical, Inc. · LFL Instrument, Ultrasonic Surgical
Cleared on Nov 18, 2024 as substantially equivalent to K181367 (Tenex Health, Inc., 2018) after a 158-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Nov 18, 2024
- Review
- 158 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K884413 (1988). 12 ancestors in all, the oldest K801623 (1980). No later device cites it as a predicate yet.
- Root · 5 generations backK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
- 4 generations backK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
- 3 generations backK051947 Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP · 2005
- 2 generations backK062471 Ultrasonic Surgical Aspirator System, Model FS 1000 RFMisonix, Inc. · 2006
- 1 generation backK181367 Tenex Health TX System with the TXP MicroTipTenex Health, Inc. · 2018
- This deviceK241700 Tenex 2nd Generation SystemTrice Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K884413 | Cusa System 200H Ultrasonic Surgical Aspirator | Valleylab, Inc. | 1988 | — |
| −4 | K981262 | Cusa Excel Ultrasonic Surgical Aspirator System | Valleylab, Inc. | 1998 | 3 |
| −3 | K051947 | Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone | Radionics, A Division of Tyco Healthcare Group LP | 2005 | — |
| −2 | K062471 | Ultrasonic Surgical Aspirator System, Model FS 1000 RF | Misonix, Inc. | 2006 | — |
| −1 | K181367 | Tenex Health TX System with the TXP MicroTip | Tenex Health, Inc. | 2018 | — |
| 0 (this device) | K241700 | Tenex 2nd Generation System | Trice Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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 LFL? 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 LFL device
- #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 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 |
|---|---|---|---|
| * | K181367 | Tenex Health TX System with the TXP MicroTipSummary page 5…rgical Device Class: Unclassified Panel: General & Plastic Surgery Product Code: LFL Predicate Devices: K181367, Tenex Health TX System with the TXP MicroTip, Product Code: LFL Device Description: The Tenex 2nd… | 2018 |
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 36 years and passes through 5 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 12 ancestors have a recall of any class.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LFL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFL
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFL
11in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFL
3,857in 2025
MAUDE reports naming product code LFL, 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 | 7 | 99 | 0 | 2,236 |
| 2008 | 2 | — | 0 | 1,678 |
| 2009 | 1 | — | 0 | 3,324 |
| 2010 | 2 | — | 3 | 1,239 |
| 2011 | 3 | 241 | 2 | 1,053 |
| 2012 | 3 | 82 | 5 | 1,491 |
| 2013 | 5 | 73 | 0 | 2,430 |
| 2014 | 3 | 136 | 1 | 4,260 |
| 2015 | 4 | 99 | 1 | 2,777 |
| 2016 | 5 | 111 | 0 | 2,691 |
| 2017 | 2 | — | 1 | 3,267 |
| 2018 | 3 | 66 | 0 | 3,461 |
| 2019 | 4 | 103 | 42 | 3,153 |
| 2020 | 4 | 190 | 0 | 2,934 |
| 2021 | 6 | 83 | 1 | 3,289 |
| 2022 | 8 | 168 | 0 | 3,422 |
| 2023 | 4 | 104 | 2 | 4,215 |
| 2024 | 3 | 158 | 11 | 4,017 |
| 2025 | 3 | 176 | 0 | 3,857 |
| 2026 | 3 | 99 | 1 | — |
What is it indicated for?
The Tenex® 2nd Generation System is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of both soft and hard (e.g.: bone) tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery, and Plastic and Reconstructive Surgery.
The Tenex® 2nd Generation System is also indicated for use in the debridement of wounds, such as, but not limited to diabetic ulcers, in application, in which, in the physician’s judgement would require the use of an ultrasonic aspirator with sharp debridement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241700: Tenex 2nd Generation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241700
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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