FDA applicant

Zoll Manufacturing Corporation

Pittsburgh, PA4 decisions2001–20196 recalls

FDA records 4 decisions for Zoll Manufacturing Corporation (Pittsburgh, PA) from 2001 to 2019: 3 510(k) clearances and 1 original PMA approval. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and DPS (Electrocardiograph). Since 2016 its 510(k)s took a median of 253 days from receipt to decision, against 203 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. 6 recalls are linked to its devices.

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

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

How often FDA has decided Zoll Manufacturing Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2007high 2 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2007high 2 (2007) · low 0 (2009)2026

Class I Class II/III not classified

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

Planning a device like Zoll Manufacturing Corporation’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 “Zoll”

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

ZOLL Medical Corporation 69 Zoll Medical Corporation, World Wide Headquarters 21 Zoll Circulation, Inc. 14 Zoll Respicardia, Inc. 1

Zoll Manufacturing Corporation

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Zoll”