FDA product code · General Hospital · Class 2
FPA: Set, Administration, Intravascular
FPA is FDA's product code for "Set, Administration, Intravascular": a Class 2 device classified under 21 CFR 880.5440, reviewed by the General Hospital panel.
510(k) review time for FPA
Across 84 510(k) clearances under FPA decided from 2018-01-01 to 2026-10-06, the median was 232 days from FDA receipt to decision. Half took between 140 and 311 days, and 80% were decided within 364 days. These are past clearances, not a forecast for a new submission.
| Fastest | 26 |
|---|---|
| 25th percentile | 140 |
| Median | 232 |
| 75th percentile | 311 |
| 80th percentile | 364 |
| 90th percentile | 430 |
| Slowest | 577 |
| Year | Median days | n |
|---|---|---|
| 2019 | 161 | 7 |
| 2020 | 327 | 10 |
| 2021 | 186 | 13 |
| 2022 | 213 | 14 |
| 2023 | 340 | 14 |
| 2024 | 244 | 7 |
| 2025 | 225 | 11 |
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.
FPA in the public FDA record
| 510(k) clearances, all years | 1,174 |
|---|---|
| Device recalls | 1,088 |
| Establishment listings | 2,228 |
| GUDID device identifiers | 9,819 |
Counts of records, not of devices or events. Adverse event reports for FPA 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 FPA
10 FDA recognized consensus standards cite FPA, 3 of them recognized only in part, among them ISO 80369-6 First Edition 2016-03-15; ISO 80369-6 Second edition 2025-05; ISO 8536-5 Second edition 2004-02-01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 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.
- 5-146 ISO 80369-6 Second edition 2025-05 — Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
- 6-122 ISO 8536-5 Second edition 2004-02-01 — Infusion equipment for medical use - Part 5: Burette infusion sets for single use gravity feed
- 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
- 6-359 ISO 8536-9 Second Edition 2015-06-15 (partial recognition) — Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment
- 6-360 ISO 8536-10 Second Edition 2015-06-15 (partial recognition) — Infusion Equipment for Medical Use - Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment
- 6-361 ISO 8536-11 Second Edition 2015-06-15 (partial recognition) — Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment
- 6-447 ISO 8536-4 Sixth edition 2019-09 — Infusion equipment for medical use - Part 4: Infusion sets for single use gravity feed
- 6-481 ANSI AAMI CN27:2021 — General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
- 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.