FDA product code MMK: Container, Sharps
MMK is the FDA product code for container, sharps. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel. FDA has cleared 112 510(k) submissions under MMK, 7 in the last five years, from 77 different applicants. The average 510(k) review took 121 days (median 90); 86 days on average over the last three years. FDA has posted 3 recalls for MMK devices.
Classification
| Field | Value |
|---|---|
| Device name | Container, Sharps |
| Device class | Class II |
| Regulation | 21 CFR 880.5570 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MMK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 253 |
| 2018 | 1 | 245 |
| 2019 | 4 | 230 |
| 2020 | 1 | 157 |
| 2021 | 3 | 182 |
| 2022 | 1 | 265 |
| 2023 | 3 | 210 |
| 2025 | 3 | 86 |
Compare with all 510(k) review times · Search every MMK clearance
Top MMK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bemis Mfg. Co. | 7 | 1997-02-11 |
| Sage Products, Inc. | 5 | 1998-02-24 |
| Anago, Inc. | 5 | 1986-05-02 |
| Ningbo Maxcon Medical Technology Co., Ltd. | 4 | 2023-06-16 |
| Pureway Compliance, Inc. | 3 | 2025-10-14 |
72 more applicants have MMK clearances. See the full list in Caduvo.
Most recent MMK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253222 | Zhejiang Gongdong Medical Technology Co., Ltd. | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | 2025-12-22 | 84 |
| K251874 | Pureway Compliance, Inc. | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) | 2025-10-14 | 118 |
| K252637 | Keter Canada, Inc. | Community Containers (Flap and Daisy) | 2025-10-14 | 55 |
| K231484 | Pureway Compliance, Inc. | PureWay 1.4 Quart Sharps Collector | 2023-09-14 | 114 |
| K222906 | Ningbo Maxcon Medical Technology Co., Ltd. | Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 | 2023-06-16 | 266 |
Recalls for MMK devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-08-23.
Frequently asked questions
What is FDA product code MMK?
MMK is the FDA product code for container, sharps. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel.
What device class is MMK?
Class II, regulation 21 CFR 880.5570. Typical premarket route: 510(k).
How long does a 510(k) take for product code MMK?
Across 112 cleared submissions the average was 121 days from receipt to decision (median 90).
Which companies have the most MMK clearances?
Bemis Mfg. Co. (7); Sage Products, Inc. (5); Anago, Inc. (5); Ningbo Maxcon Medical Technology Co., Ltd. (4); Pureway Compliance, Inc. (3).
Have MMK devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2006-08-23.
Next steps
- Run an FDA pathway report with predicate devices for product code MMK
- Run a recall and safety report across every MMK manufacturer
- Watch product code MMK 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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