FDA product code NMD: Oximeter, Tissue Saturation, Reprocessed
NMD is the FDA product code for oximeter, tissue saturation, reprocessed. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under NMD, from 2 different applicants. The average 510(k) review took 64 days (median 64).
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Oximeter, Tissue Saturation, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 870.2700 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NMD clearance
Top NMD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Midwest Reprocessing Center, LLC | 1 | 2011-06-08 |
| Hygia Health Services, Inc. | 1 | 2010-05-04 |
Most recent NMD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K111007 | Midwest Reprocessing Center, LLC | MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE | 2011-06-08 | 58 |
| K100523 | Hygia Health Services, Inc. | ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA | 2010-05-04 | 69 |
Recalls for NMD devices
openFDA lists no recalls for product code NMD.
Frequently asked questions
What is FDA product code NMD?
NMD is the FDA product code for oximeter, tissue saturation, reprocessed. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the Cardiovascular panel.
What device class is NMD?
Class II, regulation 21 CFR 870.2700. Typical premarket route: 510(k).
How long does a 510(k) take for product code NMD?
Across 2 cleared submissions the average was 64 days from receipt to decision (median 64).
Which companies have the most NMD clearances?
Midwest Reprocessing Center, LLC (1); Hygia Health Services, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NMD
- Run a recall and safety report across every NMD manufacturer
- Watch product code NMD 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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