510(k) Report

FDA applicant

Collins Medical, Inc.

Braintree, MA4 decisions1999–20030 recalls

FDA records 4 decisions for Collins Medical, Inc. (Braintree, MA) from 1999 to 2003: 4 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and BZC (Calculator, Pulmonary Function Data). Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

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

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

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

FDA decisions per year

No FDA decision for Collins Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • BZGSpirometer, Diagnostic3decisions
  • BZCCalculator, Pulmonary Function Data1decision

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K992743Collins CPLCollins Medical, Inc. · 19993cite it
  • K011344Infant Plethysmograph, Model 004400; Pediatric Plethysmograph, Model 004400Collins Medical, Inc. · 20021cites it
  • K030464Gem, Model 004110Collins Medical, Inc. · 20031cites it

What has FDA decided for it lately?

  • K030917Gem; Hawk; Eagle; Models 004110, 0044120, 004130Collins Medical, Inc. · 2003
  • K030464Gem, Model 004110Collins Medical, Inc. · 2003
  • K011344Infant Plethysmograph, Model 004400; Pediatric Plethysmograph, Model 004400Collins Medical, Inc. · 2002
  • K992743Collins CPLCollins Medical, Inc. · 1999

All 4 as Collins Medical, Inc. →