FDA product code MMO: Tray, Surgical, Ent
MMO is the FDA product code for tray, surgical, ent. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under MMO. The average 510(k) review took 94 days (median 94). FDA has posted 6 recalls for MMO devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tray, Surgical, Ent |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Top MMO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Hospital Supply Corp. | 1 | 1977-09-12 |
Most recent MMO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K771049 | American Hospital Supply Corp. | ENDOSCOPIC TRAY | 1977-09-12 | 94 |
Recalls for MMO devices
6 product recalls in 6 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2026-03-19.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code MMO?
MMO is the FDA product code for tray, surgical, ent. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is MMO?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MMO?
Across 1 cleared submissions the average was 94 days from receipt to decision (median 94).
Which companies have the most MMO clearances?
American Hospital Supply Corp. (1).
Have MMO devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2026-03-19.
Next steps
- Run an FDA pathway report with predicate devices for product code MMO
- Run a recall and safety report across every MMO manufacturer
- Watch product code MMO 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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