FDA applicant

Pari Respiratory Equipment, Inc.

Midlothian, VA10 decisions2009–20250 recalls

FDA records 10 decisions for Pari Respiratory Equipment, Inc. (Midlothian, VA) from 2009 to 2025: 10 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and BWF (Spirometer, Therapeutic (Incentive)). Since 2016 its 510(k)s took a median of 232 days from receipt to decision, against 219 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 5 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 Pari Respiratory Equipment, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009high 3 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Pari Respiratory Equipment, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pari Respiratory Equipment, 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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Other applicant names beginning “Pari”

FDA records each applicant name separately; these may or may not be the same firm.

Pari Innovative Manufacturers, Inc. 10 Pari Holding Co. 8

Pari Respiratory Equipment, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Pari”