510(k) Report

FDA applicant

Tenex Health, Inc.

Lake Forest,, CA3 decisions2013–20181 recall

FDA records 3 decisions for Tenex Health, Inc. (Lake Forest,, CA) from 2013 to 2018: 3 510(k) clearances. All are in product code LFL (Instrument, Ultrasonic Surgical). Its devices cite 4 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Tenex Health”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Tenex Health, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2013: 12016: 12018: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2014

2014: 1
2013high 1 (2014) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Tenex Health, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tenex Health, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LFLInstrument, Ultrasonic Surgical3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123640TX1 Tissue Removal SystemTenex Health · 20131cites it
  • K181367Tenex Health TX System with the TXP MicroTipTenex Health, Inc. · 20181cites it
  • K153299Tenex Health TX SystemTenex Health, Inc. · 20161cites it

What has FDA decided for it lately?

  • K181367Tenex Health TX System with the TXP MicroTipTenex Health, Inc. · 2018
  • K153299Tenex Health TX SystemTenex Health, Inc. · 2016
  • K123640TX1 Tissue Removal SystemTenex Health · 20131 recall

All 2 as Tenex Health, Inc. →The one decision as Tenex Health →

What has been recalled?

1 recall linked to its devices; the latest:

  • K123640TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip…Apr 14, 2014Class II