510(k) Report

FDA applicant

Med Systems

Santa Monica, CA4 decisions1985–20210 recalls

FDA records 4 decisions for Med Systems (Santa Monica, CA) from 1985 to 2021: 4 510(k) clearances. Most are in product codes BYI (Percussor, Powered-Electric) and CAW (Generator, Oxygen, Portable). Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Med Systems, Inc.”.

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 Med Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Med Systems’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?

  • BYIPercussor, Powered-Electric2decisions
  • CAWGenerator, Oxygen, Portable1decision
  • BSJMask, Gas, Anesthetic1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K031876Electro Flo Percussor, Model 5000Med Systems · 20032cite it

What has FDA decided for it lately?

  • K201490Electro Flo 6 Airway Clearance SystemMed Systems, Inc. · 2021
  • K031876Electro Flo Percussor, Model 5000Med Systems · 2003
  • K941145Oxy-GeneratorMed Systems · 1995
  • K853785Series 2000 Meds MaskMed Systems · 1985

All 3 as Med Systems →The one decision as Med Systems, Inc. →