FDA product code · General Hospital · Class 2
FMI: Needle, Hypodermic, Single Lumen
FMI is FDA's product code for "Needle, Hypodermic, Single Lumen": a Class 2 device classified under 21 CFR 880.5570, reviewed by the General Hospital panel.
510(k) review time for FMI
Across 127 510(k) clearances under FMI decided from 2018-01-01 to 2026-10-06, the median was 163 days from FDA receipt to decision. Half took between 87 and 243 days, and 80% were decided within 261 days. These are past clearances, not a forecast for a new submission.
| Fastest | 23 |
|---|---|
| 25th percentile | 87 |
| Median | 163 |
| 75th percentile | 243 |
| 80th percentile | 261 |
| 90th percentile | 353 |
| Slowest | 753 |
| Year | Median days | n |
|---|---|---|
| 2018 | 176 | 20 |
| 2019 | 186 | 12 |
| 2020 | 267 | 10 |
| 2021 | 143 | 18 |
| 2022 | 189 | 23 |
| 2023 | 112 | 18 |
| 2025 | 141 | 11 |
| 2026 (to 10-06, partial) | 119 | 12 |
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.
FMI in the public FDA record
| 510(k) clearances, all years | 693 |
|---|---|
| Device recalls | 309 |
| Establishment listings | 1,320 |
| GUDID device identifiers | 6,413 |
Counts of records, not of devices or events. Adverse event reports for FMI 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 FMI
11 FDA recognized consensus standards cite FMI, 1 of them recognized only in part, among them ISO 80369-7 Second edition 2021-05; ISO 23908 First edition 2011-06-11; ISO 11040-5 Third edition 2012-02-15. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 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
- 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
- 6-379 ISO 7864 Fourth edition 2016-08-01 — Sterile hypodermic needles for single use - Requirements and test methods
- 6-380 ISO 9626 Second edition 2016-08-01 — Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- 6-381 ISO 6009 Fourth edition 2016-08-01 — Hypodermic needles for single use - Colour coding for identification.
- 6-400 ASTM F3212-16(2023) — Standard Test Method for Coring Testing of Huber Needles
- 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)]
- 6-507 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.