FDA product code · Cardiovascular

Low Patient Acuity Monitoring System

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

PFYClass II21 CFR 870.2300510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

For non-continuous central monitoring of patient parameters, including cardiac parameters, in low risk patients.

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, cardiovascular panel

Twenty years of PFY 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 — PFY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PFY? 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

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