510(k) Report

FDA applicant

Hewlett-Packard Co.

Mchenry, IL246 decisions1976–200015 recalls

FDA records 246 decisions for Hewlett-Packard Co. (Mchenry, IL) from 1976 to 2000: 246 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and DRT (Monitor, Cardiac (Incl. Cardiotachometer &…). Its devices cite 95 predicates, 69 of them its own earlier devices. 15 recalls are linked to its devices.

FDA’s records also spell it “Hewlett-Packard GmbH”.

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 Hewlett-Packard Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hewlett-Packard Co. since 2007.

Recalls per year

4in 2025

2008: 22009: 32010: 12011: 22020: 12025: 4
2007high 4 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Hewlett-Packard Co.’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 “Hewlett-Packard”

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