FDA applicant
Neothermia Corp.
FDA records 10 decisions for Neothermia Corp. (Natick, MA) from 2001 to 2005: 10 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and KNW (Instrument, Biopsy). Its devices cite 8 predicates, 6 of them its own earlier devices. 11 recalls are linked to its devices.
FDA’s records also spell it “Neothermia Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Neothermia Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Neothermia Corp. since 2007.
Recalls per year
11in 2016
Class I Class II/III not classified
Planning a device like Neothermia 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) Report