510(k) Report

FDA applicant

Pharma Systems, Inc.

Bernardsville, NJ6 decisions1990–20101 recall

FDA records 6 decisions for Pharma Systems, Inc. (Bernardsville, NJ) from 1990 to 2010: 6 510(k) clearances. Most are in product codes BYD (Condenser, Heat And Moisture (Artificial Nose)) and CAH (Filter, Bacterial, Breathing-Circuit). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Pharma Systems AB”.

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

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Pharma Systems, 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?

  • BYDCondenser, Heat And Moisture (Artificial Nose)3decisions
  • CAHFilter, Bacterial, Breathing-Circuit2decisions
  • BZOSet, Tubing And Support, Ventilator (W Harness)1decision

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 6 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.

  • K903058Bact-Hme (TM)Pharma Systems, Inc. · 19903cite it
  • K903056BacttrapPharma Systems, Inc. · 19903cite it

What has FDA decided for it lately?

  • K093426Bact-Trap Hepa MidiPharma Systems AB · 2010
  • K903057Freevent (TM)Pharma Systems, Inc. · 1990
  • K903058Bact-Hme (TM)Pharma Systems, Inc. · 1990
  • K903055Extended Life CircuitsPharma Systems, Inc. · 1990
  • K903056BacttrapPharma Systems, Inc. · 1990
  • K903054HME-10 (TM)Pharma Systems, Inc. · 19901 recall

All 5 as Pharma Systems, Inc. →The one decision as Pharma Systems AB →

What has been recalled?

1 recall linked to its devices; the latest:

  • K903054ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a…Feb 19, 2015Class III