FDA applicant
Zoll Circulation, Inc.
FDA records 14 decisions for Zoll Circulation, Inc. (San Jose, CA) from 2006 to 2025: 13 510(k) clearances and 1 original PMA approval. Most are in product codes NCX (System, Hypothermia, Intravenous, Cooling) and DRM (Compressor, Cardiac, External). Its devices cite 29 predicates, 14 of them its own earlier devices. 29 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Zoll Circulation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Zoll Circulation, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Zoll Circulation, 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 “Zoll”
FDA records each applicant name separately; these may or may not be the same firm.