FDA applicant
Devilbiss Healthcare, LLC
FDA records 7 decisions for Devilbiss Healthcare, LLC (Somerset, PA) from 2011 to 2026: 7 510(k) clearances. Most are in product codes BZD (Ventilator, Non-Continuous (Respirator)) and CAW (Generator, Oxygen, Portable). Since 2016 its 510(k)s took a median of 168 days from receipt to decision, against 210 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Devilbiss Healthcare, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Devilbiss Healthcare, LLC’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 “Devilbiss”
FDA records each applicant name separately; these may or may not be the same firm.