510(k) Report

FDA applicant

Dallen Medical, Inc.

San Clemente, CA11 decisions2011–20170 recalls

FDA records 11 decisions for Dallen Medical, Inc. (San Clemente, CA) from 2011 to 2017: 11 510(k) clearances. Most are in product codes HTN (Washer, Bolt Nut) and JDR (Staple, Fixation, Bone). Its devices cite 31 predicates, 11 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Dallen Medical”.

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

FIG. A — Illustration, orthopedic panel, where it files most

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

FDA decisions per year

1in 2017

2011: 12013: 42014: 32015: 22017: 1
2011high 4 (2013) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Dallen Medical, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dallen Medical, 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?

  • HTNWasher, Bolt Nut5decisions
  • JDRStaple, Fixation, Bone4decisions
  • JDQCerclage, Fixation2decisions

Whose devices does it build on?

Its devices cite 31 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 11 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.

  • K131850Tensyn BandDallen Medical, Inc. · 20133cite it
  • K122871Compressyn StapleDallen Medical, Inc. · 20132cite it
  • K140358Compressyn StapleDallen Medical, Inc. · 20142cite it
  • K130431Compressyn BandDallen Medical, Inc. · 20131cites it
  • K143092Tensyn PlugDallen Medical, Inc. · 20151cites it
  • K133858Tensyn BandDallen Medical, Inc. · 20141cites it

What has FDA decided for it lately?

  • K171473Compressyn™ StapleDallen Medical, Inc. · 2017
  • K150359Tensyn PlugDallen Medical, Inc. · 2015
  • K143092Tensyn PlugDallen Medical, Inc. · 2015
  • K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc. · 2014
  • K140358Compressyn StapleDallen Medical, Inc. · 2014
  • K133858Tensyn BandDallen Medical, Inc. · 2014
  • K132875Compressyn StapleDallen Medical, Inc. · 2013
  • K131850Tensyn BandDallen Medical, Inc. · 2013

All 10 as Dallen Medical, Inc. →The one decision as Dallen Medical →