510(k) · Cleared
ClearedTenex Health TX System with the TXP MicroTip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tenex Health, Inc. · LFL Instrument, Ultrasonic Surgical
Cleared on Aug 28, 2018 as substantially equivalent to K062471 (Misonix, Inc., 2006) and 1 other predicate after a 97-day review. Its family tree reaches back 4 generations to 1988. 1 later device descends from it.
- Decided
- Aug 28, 2018
- Review
- 97 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K884413 (1988). 11 ancestors in all, the oldest K801623 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
- 3 generations backK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
- 2 generations backK051947 Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP · 2005
- 1 generation backK062471 Ultrasonic Surgical Aspirator System, Model FS 1000 RFMisonix, Inc. · 2006
- This deviceK181367 Tenex Health TX System with the TXP MicroTipTenex Health, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK241700 Tenex 2nd Generation SystemTrice Medical, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241700Tenex 2nd Generation SystemTrice Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K884413 | Cusa System 200H Ultrasonic Surgical Aspirator | Valleylab, Inc. | 1988 | — |
| −3 | K981262 | Cusa Excel Ultrasonic Surgical Aspirator System | Valleylab, Inc. | 1998 | 3 |
| −2 | K051947 | Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone | Radionics, A Division of Tyco Healthcare Group LP | 2005 | — |
| −1 | K062471 | Ultrasonic Surgical Aspirator System, Model FS 1000 RF | Misonix, Inc. | 2006 | — |
| 0 (this device) | K181367 | Tenex Health TX System with the TXP MicroTip | Tenex Health, Inc. | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K062471 | Ultrasonic Surgical Aspirator System, Model FS 1000 RFSummary page 4…e: LFL Classification Name: Instrument, Ultrasonic Surgical Predicate Devices: Ultrasonic Surgical Aspirator System Model FS 1000 RF (K062471) AUSS-6 Ultrasonic Surgical Aspirator System and Accessories (K050776)… | 2006 |
| * | K050776 | Auss-6 Ultrasonic Surgical Aspirator SystemSummary page 4…es: Ultrasonic Surgical Aspirator System Model FS 1000 RF (K062471) AUSS-6 Ultrasonic Surgical Aspirator System and Accessories (K050776) The Tenex Health TX System (K153299) is a reference device with regard… | 2005 |
| † | K153299 | Tenex Health TX System | 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 |
|---|---|---|---|
| K241700 | Tenex 2nd Generation System | 2024 | 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 30 years and passes through 4 companies; a new generation was cleared every 9.6 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K241700 (Trice Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K062471.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Health TX System with the TXP MicroTip 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 Health TX System with the TXP MicroTip 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/K181367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181367: Tenex Health TX System with the TXP MicroTip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181367
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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