510(k) Report

FDA applicant

Hospitak, Inc.

Mchenry, IL27 decisions1978–199623 recalls

FDA records 27 decisions for Hospitak, Inc. (Mchenry, IL) from 1978 to 1996: 27 510(k) clearances. Most are in product codes BZA (Connector, Airway (Extension)) and KPJ (Chamber, Oxygen, Topical, Extremity). 23 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, anesthesiology panel, where it files most

How often FDA has decided Hospitak, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hospitak, Inc. since 2007.

Recalls per year

23in 2009

2009: 23
2007high 23 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Hospitak, 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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