FDA applicant
Hospitech Respiration, Ltd.
FDA records 6 decisions for Hospitech Respiration, Ltd. (Binyamina, IL) from 2010 to 2022: 6 510(k) clearances. Most are in product codes BSK (Cuff, Tracheal Tube, Inflatable) and BTP (Dropper, Ether). Its devices cite 15 predicates, 3 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
How often FDA has decided Hospitech Respiration, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Hospitech Respiration, Ltd.’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