FDA applicant
Instrumentation Industries, Inc.
FDA records 46 decisions for Instrumentation Industries, Inc. (Bethel Park, PA) from 1977 to 2019: 45 510(k) clearances and 1 original PMA approval. Most are in product codes CBP (Valve, Non-Rebreathing) and CAF (Nebulizer (Direct Patient Interface)). Its devices cite 4 predicates, 4 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 Instrumentation Industries, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
1in 2012
Class I Class II/III not classified
Planning a device like Instrumentation Industries, 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 “Instrumentation”
FDA records each applicant name separately; these may or may not be the same firm.