FDA product code PMK: Cpr Aid Device Without Feedback
PMK is the FDA product code for cpr aid device without feedback. It is a Class I device, regulated under 21 CFR 870.5210 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under PMK. The average 510(k) review took 210 days (median 210).
Definition
A device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim.
Classification
| Field | Value |
|---|---|
| Device name | Cpr Aid Device Without Feedback |
| Device class | Class I |
| Regulation | 21 CFR 870.5210 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every PMK clearance
Top PMK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Green Field Medical Sourcing, Inc. | 2 | 1994-10-04 |
Most recent PMK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944667 | Green Field Medical Sourcing, Inc. | LIFE PULSE TESUSCITATION TIMER | 1994-10-04 | 14 |
| K932867 | Green Field Medical Sourcing, Inc. | LIFE PULSE RESUSCITATION TIMER | 1994-07-25 | 406 |
Recalls for PMK devices
openFDA lists no recalls for product code PMK.
Frequently asked questions
What is FDA product code PMK?
PMK is the FDA product code for cpr aid device without feedback. It is a Class I device, regulated under 21 CFR 870.5210 and reviewed by the Cardiovascular panel.
What device class is PMK?
Class I, regulation 21 CFR 870.5210. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PMK?
Across 2 cleared submissions the average was 210 days from receipt to decision (median 210).
Which companies have the most PMK clearances?
Green Field Medical Sourcing, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PMK
- Run a recall and safety report across every PMK manufacturer
- Watch product code PMK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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