FDA applicant
Busse Hospital Disposables, Inc.
FDA records 35 decisions for Busse Hospital Disposables, Inc. (Hauppauge, NY) from 1983 to 2015: 35 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and KNW (Instrument, Biopsy). Its devices cite 12 predicates, 4 of them its own earlier devices. 7 recalls are linked to its devices.
FDA’s records also spell it “Busse Hospital Disposables”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Busse Hospital Disposables, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
7in 2017
Class I Class II/III not classified
Planning a device like Busse Hospital Disposables, 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) ReportOther applicant names beginning “Busse”
FDA records each applicant name separately; these may or may not be the same firm.