FDA product code · Cardiovascular
Cpr Aid Feedback Device (No Software)
FDA lists PMJ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 870.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.
Provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR in accordance with current accepted CPR guidelines
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PMJ 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.
Planning a device in PMJ? 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) ReportRelated product codes
Other codes under 21 CFR 870.5210.