FDA product code NHM: Sheet, Recording, Breast Examination
NHM is the FDA product code for sheet, recording, breast examination. It is a Class II device, regulated under 21 CFR 884.2990 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under NHM, from 2 different applicants. The average 510(k) review took 75 days (median 75).
Definition
This recording sheet is intended to for clinicians to mark the locationof a palpable breast lump identified by a clinical breast examination.
Classification
| Field | Value |
|---|---|
| Device name | Sheet, Recording, Breast Examination |
| Device class | Class II |
| Regulation | 21 CFR 884.2990 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NHM clearance
Top NHM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rusin Medical Devices | 1 | 2002-11-26 |
| James D Rusin MD, MBA | 1 | 2002-03-01 |
Most recent NHM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022861 | Rusin Medical Devices | SAFETOUCH | 2002-11-26 | 90 |
| K014300 | James D Rusin MD, MBA | SAFETOUCH | 2002-03-01 | 60 |
Recalls for NHM devices
openFDA lists no recalls for product code NHM.
Frequently asked questions
What is FDA product code NHM?
NHM is the FDA product code for sheet, recording, breast examination. It is a Class II device, regulated under 21 CFR 884.2990 and reviewed by the Obstetrics and Gynecology panel.
What device class is NHM?
Class II, regulation 21 CFR 884.2990. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NHM?
Across 2 cleared submissions the average was 75 days from receipt to decision (median 75).
Which companies have the most NHM clearances?
Rusin Medical Devices (1); James D Rusin MD, MBA (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NHM
- Run a recall and safety report across every NHM manufacturer
- Watch product code NHM 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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