FDA product code · General Hospital · Class 2
MMK: Container, Sharps
MMK is FDA's product code for "Container, Sharps": a Class 2 device classified under 21 CFR 880.5570, reviewed by the General Hospital panel.
510(k) review time for MMK
Across 18 510(k) clearances under MMK decided from 2018-01-01 to 2026-10-06, the median was 167 days from FDA receipt to decision. Half took between 120 and 265 days, and 80% were decided within 265 days. These are past clearances, not a forecast for a new submission.
| Fastest | 55 |
|---|---|
| 25th percentile | 120 |
| Median | 167 |
| 75th percentile | 265 |
| 80th percentile | 265 |
| 90th percentile | 267 |
| Slowest | 276 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
MMK in the public FDA record
| 510(k) clearances, all years | 114 |
|---|---|
| Establishment listings | 166 |
| GUDID device identifiers | 913 |
Counts of records, not of devices or events. Adverse event reports for MMK are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite MMK
5 FDA recognized consensus standards cite MMK, among them ASTM F2132-01 (Reapproved 2008)e1; ISO 23908 First edition 2011-06-11; ISO 23907-1 First edition 2019-01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 6-215 ASTM F2132-01 (Reapproved 2008)e1 — Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps
- 6-273 ISO 23908 First edition 2011-06-11 — Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles introducers for catheters and needles used for blood sampling
- 6-426 ISO 23907-1 First edition 2019-01 — Sharps injury protection - Requirements and test methods - Sharps containers
- 6-437 ISO 23907-2 First edition 2019-11 — Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers.
- 6-507 ISO 23908 Second Edition 2024-12 — Sharps injury protection - Sharps protection mechanisms for single-use needles introducers for catheters and needles used for blood testing monitoring sampling and medical substance administration - Requirements and test methods
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.