510(k) Report

FDA applicant

Gmp/Companies, Inc.

Fort Lauderdale, FL2 decisions2003–20053 recalls

FDA records 2 decisions for Gmp/Companies, Inc. (Fort Lauderdale, FL) from 2003 to 2005: 2 510(k) clearances. Most are in product codes DRG (Transmitters And Receivers, Physiological…) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 2 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

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

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

How often FDA has decided Gmp/Companies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gmp/Companies, Inc. since 2007.

Recalls per year

3in 2007

2007: 3
2007high 3 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Gmp/Companies, 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?

  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1decision
  • GCJLaparoscope, General & Plastic Surgery1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 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.

  • K030795Lifesyne SystemsGmp/Companies, Inc. · 20034cite it
  • K050027Laparocision Scope Controller SystemGmp/Companies, Inc. · 20051cites it

What has FDA decided for it lately?

  • K050027Laparocision Scope Controller SystemGmp/Companies, Inc. · 2005
  • K030795Lifesyne SystemsGmp/Companies, Inc. · 20033 recalls

All 2 as Gmp/Companies, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K030795LS-232 Large 12 LeadWear Single Pack - Disposable ECG Monitoring component intended for…Dec 13, 2007
  • K030795LS-202 Large LeadWear Combo Pack - Disposable ECG Monitoring component intended for use…Dec 13, 2007
  • K030795LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223Jan 10, 2007