FDA product code · General Hospital · Class 2
FMF: Syringe, Piston
FMF is FDA's product code for "Syringe, Piston": a Class 2 device classified under 21 CFR 880.5860, reviewed by the General Hospital panel.
510(k) review time for FMF
Across 136 510(k) clearances under FMF decided from 2018-01-01 to 2026-10-06, the median was 169 days from FDA receipt to decision. Half took between 90 and 258 days, and 80% were decided within 269 days. These are past clearances, not a forecast for a new submission.
| Fastest | 23 |
|---|---|
| 25th percentile | 90 |
| Median | 169 |
| 75th percentile | 258 |
| 80th percentile | 269 |
| 90th percentile | 412 |
| Slowest | 832 |
| Year | Median days | n |
|---|---|---|
| 2018 | 87 | 8 |
| 2019 | 146 | 11 |
| 2020 | 107 | 15 |
| 2021 | 175 | 20 |
| 2022 | 211 | 24 |
| 2023 | 173 | 22 |
| 2024 | 130 | 14 |
| 2025 | 114 | 13 |
| 2026 (to 10-06, partial) | 239 | 9 |
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.
FMF in the public FDA record
| 510(k) clearances, all years | 752 |
|---|---|
| Device recalls | 305 |
| Establishment listings | 1,397 |
| GUDID device identifiers | 6,164 |
Counts of records, not of devices or events. Adverse event reports for FMF 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 FMF
20 FDA recognized consensus standards cite FMF, 2 of them recognized only in part, among them ISO 26825 Second edition 2020-10; ISO 80369-6 First Edition 2016-03-15; ISO 80369-7 Second edition 2021-05. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 1-147 ISO 26825 Second edition 2020-10 — Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours design and performance
- 5-108 ISO 80369-6 First Edition 2016-03-15 — Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
- 5-133 ISO 80369-7 Second edition 2021-05 — Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- 5-146 ISO 80369-6 Second edition 2025-05 — Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
- 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
- 6-278 ISO 11040-5 Third edition 2012-02-15 — Prefilled syringes - Part 5: Plunger stoppers for injectables
- 6-364 ISO 8537 Third edition 2016-03-15 (partial recognition) — Sterile single-use syringes with or without needle for insulin
- 6-382 ISO 11608-7 First edition 2016-08-01 — Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment
- 6-404 ISO 7886-1 Second edition 2017-05 — Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- 6-439 ISO 7886-2 Second edition 2020-04 (partial recognition) — Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
- 6-441 ISO 7886-3 Second edition 2020-05 — Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization
- 6-464 ISO 11040-4 Third edition 2015-04-01 — Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)]
- 6-475 ISO 11608-4:2022 — Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
- 6-476 ISO 11608-2:2022 — Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
- 6-477 ISO 11608-3:2022 — Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
The first 15 of 20 are shown. Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.