FDA applicant
Perimed, Inc.
FDA records 10 decisions for Perimed, Inc. (Jarfalla, SE) from 1989 to 2016: 10 510(k) clearances. Most are in product codes DPW (Flowmeter, Blood, Cardiovascular) and LKD (Monitor, Carbon-Dioxide, Cutaneous). Its devices cite 10 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Perimed AB”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Perimed, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Perimed, 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) Report