FDA applicant
Impact Instrumentation, Inc.
FDA records 27 decisions for Impact Instrumentation, Inc. (West Caldwell, NJ) from 1981 to 2014: 27 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and BTL (Ventilator, Emergency, Powered (Resuscitator)). Its devices cite 18 predicates, 10 of them its own earlier devices. 5 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Impact Instrumentation, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Impact Instrumentation, 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 “Impact”
FDA records each applicant name separately; these may or may not be the same firm.