510(k) · Cleared
ClearedTenex Health TX System
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 Mar 3, 2016 as substantially equivalent to K123640 (Tenex Health, 2013) after a 111-day review. Its family tree reaches back 5 generations to 1988. 1 later device descends from it.
- Decided
- Mar 3, 2016
- Review
- 111 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K884413 (1988). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK021989 Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences · 2002 · Recalled
- 2 generations backK101561 TX1 Tissue Removal SystemAmerican Optisurgical, Inc. · 2010 · Recalled
- 1 generation backK123640 TX1 Tissue Removal SystemTenex Health · 2013 · Recalled
- This deviceK153299 Tenex Health TX SystemTenex Health, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK212049 Oclet TDS 1000Tendonova Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K212049Oclet TDS 1000Tendonova Corporation · 2022 · cites it directly0descendants
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 | K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3 | Integra Neurosciences | 2002 | 2 |
| −2 | K101561 | TX1 Tissue Removal System | American Optisurgical, Inc. | 2010 | 2 |
| −1 | K123640 | TX1 Tissue Removal System | Tenex Health | 2013 | 1 |
| 0 (this device) | K153299 | Tenex Health TX System | Tenex Health, Inc. | 2016 | — |
| +1 | K212049 | Oclet TDS 1000 | Tendonova Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K123640 | TX1 Tissue Removal SystemSummary page 4…Unclassified Product Code(s) LFL 807.92(a)(3) – Legally marketed device(s) to which equivalence is claimed TX1 Tissue Removal System K123640 807.92(a)(4) – Device description The Tenex Health TX System is an ultrasonic surgical aspirator that fragments, emulsifies and… | 2013 |
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 |
|---|---|---|---|
| K212049 | Oclet TDS 1000 | 2022 | 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 28 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 10 ancestors have a recall of any class.
- Of its descendants, K212049 (Tendonova Corporation, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153299 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153299: Tenex Health TX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153299
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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