FDA applicant
Hospitak, Inc.
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
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
2007high 23 (2009) · low 0 (2007)2026
Class I Class II/III not classified
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.
See the 510(k) Report