510(k) Report

FDA applicant

Perimed, Inc.

Jarfalla, SE10 decisions1989–20160 recalls

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, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Perimed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2012: 12013: 12016: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Perimed, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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