FDA applicant
Pelton & Crane Co.
FDA records 16 decisions for Pelton & Crane Co. (Charlotte, NC) from 1976 to 2018: 16 510(k) clearances. Most are in product codes EIA (Unit, Operative Dental) and EAP (Unit, X-Ray, Intraoral). Its devices cite 3 predicates, 0 of them its own earlier devices. 6 recalls are linked to its devices.
FDA’s records also spell it “Pelton & Crane”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pelton & Crane Co.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
1in 2012
Class I Class II/III not classified
Planning a device like Pelton & Crane Co.’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