FDA applicant
Puritan Bennett Corp.
FDA records 114 decisions for Puritan Bennett Corp. (Overland Park, KS) from 1976 to 2007: 114 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and BTM (Ventilator, Emergency, Manual (Resuscitator)). Its devices cite 37 predicates, 19 of them its own earlier devices. 10 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Puritan-Bennett”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Puritan Bennett Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2007
2026 so far, outlined.
Recalls per year
2in 2014
Class I Class II/III not classified
Planning a device like Puritan Bennett Corp.’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 “Puritan”
FDA records each applicant name separately; these may or may not be the same firm.