510(k) Report

FDA applicant

Demetech Corp.

Miami Lakes, FL16 decisions2002–20200 recalls

FDA records 16 decisions for Demetech Corp. (Miami Lakes, FL) from 2002 to 2020: 16 510(k) clearances. Most are in product codes NEW (Suture, Surgical, Absorbable, Polydioxanone) and GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). Since 2016 its 510(k)s took a median of 118 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 29 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Demetech Corporation”, “Demetech AB”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Demetech Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2008: 12010: 12013: 12014: 22018: 22019: 22020: 1
2007high 2 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Demetech Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Demetech Corp.’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?

  • NEWSuture, Surgical, Absorbable, Polydioxanone3decisions
  • GAMSuture, Absorbable, Synthetic, Polyglycolic Acid3decisions
  • GATSuture, Nonabsorbable, Synthetic, Polyethylene2decisions
  • FXXMask, Surgical1decision
  • GARSuture, Nonabsorbable, Synthetic, Polyamide1decision
  • KGIDensitometer, Bone1decision

Also: GAW (1), NBY (1), GAL (1), GAQ (1), GAP (1).

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 118 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 113 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 29 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 2 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.

  • K201479DemeMASKDemetech Corporation · 202013cite it
  • K181582DemeTECH DemeDIOX absorbable surgical sutureDemetech Corporation · 20182cite it
  • K082097Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable SutureDemetech Corp. · 20102cite it
  • K043330Polypropilene Surgical SuturesDemetech Corp. · 20051cites it
  • K130083Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable SutureDemetech Corp. · 20131cites it
  • K023030Demetech Polyester Nonabsorbable SutureDemetech Corp. · 20031cites it

What has FDA decided for it lately?

  • K201479DemeMASKDemetech Corporation · 2020
  • K191361DemeDIOX Barbed Absorbable Surgical SutureDemetech Corporation · 2019
  • K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation · 2019
  • K181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation · 2018
  • K181582DemeTECH DemeDIOX absorbable surgical sutureDemetech Corporation · 2018
  • K141007Demesteel (Stainless Steel) Non-Absorbable SutureDemetech Corp. · 2014
  • K123940Demequicktm (Rapid Absorbable) Synthetic Surgical SutureDemetech Corp. · 2014
  • K130083Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable SutureDemetech Corp. · 2013

All 10 as Demetech Corp. →All 5 as Demetech Corporation →The one decision as Demetech AB →