FDA applicant

Affinity Medical Technologies, LLC

Irvine, CA1 decision1998–19980 recalls

FDA records 1 decision for Affinity Medical Technologies, LLC (Irvine, CA) in 1998: 1 510(k) clearance. All are in product code DSA (Cable, Transducer And Electrode, Patient…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

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 Affinity Medical Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Affinity Medical Technologies, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Affinity Medical Technologies, LLC’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

Other applicant names beginning “Affinity”

FDA records each applicant name separately; these may or may not be the same firm.

Affinity Biologicals, Inc. 5 Affinity Biosensors, LLC 3

Affinity Medical Technologies, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Affinity”