FDA product code MUD: Oximeter, Tissue Saturation
MUD is the FDA product code for oximeter, tissue saturation. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the General and Plastic Surgery panel. FDA has cleared 73 510(k) submissions under MUD, 11 in the last five years, from 24 different applicants. The average 510(k) review took 153 days (median 120); 167 days on average over the last three years. FDA has posted 6 recalls for MUD devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Oximeter, Tissue Saturation |
| Device class | Class II |
| Regulation | 21 CFR 870.2700 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MUD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 257 |
| 2018 | 3 | 208 |
| 2019 | 7 | 149 |
| 2020 | 2 | 103 |
| 2021 | 2 | 137 |
| 2022 | 2 | 79 |
| 2023 | 2 | 214 |
| 2024 | 5 | 138 |
| 2025 | 2 | 196 |
Compare with all 510(k) review times · Search every MUD clearance
Top MUD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cas Medical Systems, Inc. | 9 | 2019-10-21 |
| Hutchinson Technology, Inc. | 8 | 2011-03-02 |
| Vioptix, Inc. | 7 | 2024-02-28 |
| Masimo Corporation | 6 | 2025-07-17 |
| Nonin Medical, Inc. | 5 | 2019-05-02 |
19 more applicants have MUD clearances. See the full list in Caduvo.
Most recent MUD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243324 | Masimo Corporation | Masimo O3 Regional Oximeter | 2025-07-17 | 267 |
| K250519 | ViOptix, Inc. | Lap.Ox Laparoscopic Tissue Oximeter | 2025-06-26 | 125 |
| K240596 | Edwards Lifesciences | Cerebral Autoregulation Index (CAI) Algorithm | 2024-10-16 | 226 |
| K241393 | Odi Medical AS | ODI-Tech | 2024-08-30 | 106 |
| K240601 | Kent Imaging, Inc. | SnapshotNIR model KD205 | 2024-04-02 | 29 |
Recalls for MUD devices
6 product recalls in 4 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2024-01-09.
| Year | Recalls |
|---|---|
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code MUD?
MUD is the FDA product code for oximeter, tissue saturation. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the General and Plastic Surgery panel.
What device class is MUD?
Class II, regulation 21 CFR 870.2700. Typical premarket route: 510(k).
How long does a 510(k) take for product code MUD?
Across 73 cleared submissions the average was 153 days from receipt to decision (median 120).
Which companies have the most MUD clearances?
Cas Medical Systems, Inc. (9); Hutchinson Technology, Inc. (8); Vioptix, Inc. (7); Masimo Corporation (6); Nonin Medical, Inc. (5).
Have MUD devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2024-01-09.
Next steps
- Run an FDA pathway report with predicate devices for product code MUD
- Run a recall and safety report across every MUD manufacturer
- Watch product code MUD 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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