510(k) Report

FDA applicant

Pds Healthcare Products, Inc.

Louisville, CO2 decisions2001–20010 recalls

FDA records 2 decisions for Pds Healthcare Products, Inc. (Louisville, CO) in 2001: 2 510(k) clearances. All are in product code BZH (Meter, Peak Flow, Spirometry). Its devices cite 1 predicate, 1 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 Pds Healthcare Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pds Healthcare Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pds Healthcare Products, 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?

  • BZHMeter, Peak Flow, Spirometry2decisions

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.

  • K010009Koko Peak KP; Koko Peak KP+Pds Healthcare Products, Inc. · 20012cite it

What has FDA decided for it lately?

  • K013489KP + LFMPds Healthcare Products, Inc. · 2001
  • K010009Koko Peak KP; Koko Peak KP+Pds Healthcare Products, Inc. · 2001

All 2 as Pds Healthcare Products, Inc. →