FDA product code · General Hospital · Class 2
KPE: Container, I.V.
KPE is FDA's product code for "Container, I.V.": a Class 2 device classified under 21 CFR 880.5025, reviewed by the General Hospital panel.
510(k) review time for KPE
Across 14 510(k) clearances under KPE decided from 2018-01-01 to 2026-10-06, the median was 200 days from FDA receipt to decision. Half took between 98 and 268 days, and 80% were decided within 269 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 98 |
| Median | 200 |
| 75th percentile | 268 |
| 80th percentile | 269 |
| 90th percentile | 273 |
| Slowest | 297 |
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.
KPE in the public FDA record
| 510(k) clearances, all years | 117 |
|---|---|
| Device recalls | 62 |
| Establishment listings | 153 |
| GUDID device identifiers | 539 |
Counts of records, not of devices or events. Adverse event reports for KPE 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 KPE
1 FDA recognized consensus standard cite KPE, among them ISO 15747 Third edition 2018-09. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 6-501 ISO 15747 Third edition 2018-09 — Plastic containers for intravenous injections
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.