FDA product code · Clinical chemistry

Refractometer For Donor Testing

Name: FDA decisions, review times, recalls and adverse event reports for product code PSM
Creator: 510(k) Report

PSMClass I21 CFR 862.2800510(k) exempt0 decisions0 recalls

FDA lists PSM as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

For total protein testing of plasma donors to determine eligibility.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical chemistry panel

Twenty years of PSM at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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

Planning a device in PSM? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 862.2800.

JRE Refractometer For Clinical Use