FDA product code · General Hospital · Class 2
FRN: Pump, Infusion
FRN is FDA's product code for "Pump, Infusion": a Class 2 device classified under 21 CFR 880.5725, reviewed by the General Hospital panel.
510(k) review time for FRN
Across 36 510(k) clearances under FRN decided from 2018-01-01 to 2026-10-06, the median was 220 days from FDA receipt to decision. Half took between 92 and 299 days, and 80% were decided within 412 days. These are past clearances, not a forecast for a new submission.
| Fastest | 24 |
|---|---|
| 25th percentile | 92 |
| Median | 220 |
| 75th percentile | 299 |
| 80th percentile | 412 |
| 90th percentile | 484 |
| Slowest | 1,079 |
| Year | Median days | n |
|---|---|---|
| 2022 | 268 | 6 |
| 2023 | 265 | 7 |
| 2024 | 103 | 5 |
| 2025 | 172 | 8 |
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.
FRN in the public FDA record
| 510(k) clearances, all years | 849 |
|---|---|
| Device recalls | 721 |
| Establishment listings | 430 |
| GUDID device identifiers | 950 |
Counts of records, not of devices or events. Adverse event reports for FRN 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 FRN
7 FDA recognized consensus standards cite FRN, 1 of them recognized only in part, among them ISO 26825 Second edition 2020-10; ISO 23908 First edition 2011-06-11; ISO 9626 Second edition 2016-08-01. 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
- 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
- 6-380 ISO 9626 Second edition 2016-08-01 — Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- 6-422 AAMI TIR38:2019 — Medical device safety assurance case guidance
- 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
- 6-482 AAMI TIR101:2021 — Fluid delivery performance testing for infusion pumps
- 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.