FDA product code KPE: Container, I.V.
KPE is the FDA product code for container, i.v.. It is a Class II device, regulated under 21 CFR 880.5025 and reviewed by the General Hospital panel. FDA has cleared 117 510(k) submissions under KPE, 8 in the last five years, from 72 different applicants. The average 510(k) review took 108 days (median 73); 115 days on average over the last three years. FDA has posted 62 recalls for KPE devices, 25 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Container, I.V. |
| Device class | Class II |
| Regulation | 21 CFR 880.5025 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KPE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 3 | 174 |
| 2020 | 1 | 216 |
| 2021 | 2 | 228 |
| 2023 | 2 | 218 |
| 2024 | 1 | 30 |
| 2025 | 2 | 44 |
| 2026 | 3 | 270 |
Compare with all 510(k) review times · Search every KPE clearance
Top KPE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxter Healthcare Corp | 7 | 2011-06-14 |
| Abbott Laboratories | 6 | 1989-12-01 |
| Baxa Corp., Sub. of Cook Group, Inc. | 5 | 1983-07-26 |
| Gil-Med Industries C/O Kegan & Kegan, Ltd. | 4 | 1988-05-20 |
| Williams Medical Co. | 4 | 1985-11-06 |
67 more applicants have KPE clearances. See the full list in Caduvo.
Most recent KPE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252079 | Beijing L&Z Medical Technology Development Co., Ltd. | Disposable Infusion Bag for Parenteral Nutrition | 2026-04-02 | 274 |
| K251980 | Icu Medical, Inc. | ClaveQS Bag | 2026-03-20 | 266 |
| K251139 | Fresenius Kabi AG | KabiHelp® Uno; KabiHelp® Advance plus | 2026-01-09 | 270 |
| K252094 | Epic Medical Pte. , Ltd. | eZSURE Empty Fluid Container | 2025-08-01 | 29 |
| K250459 | Technoflex Sas. | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution | 2025-04-18 | 59 |
Recalls for KPE devices
62 product recalls in 16 recall events; 25 initiated in the last five years and 33 still open. Most recent: 2024-10-09.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 13 |
| 2022 | 3 |
| 2024 | 22 |
Frequently asked questions
What is FDA product code KPE?
KPE is the FDA product code for container, i.v.. It is a Class II device, regulated under 21 CFR 880.5025 and reviewed by the General Hospital panel.
What device class is KPE?
Class II, regulation 21 CFR 880.5025. Typical premarket route: 510(k).
How long does a 510(k) take for product code KPE?
Across 117 cleared submissions the average was 108 days from receipt to decision (median 73).
Which companies have the most KPE clearances?
Baxter Healthcare Corp (7); Abbott Laboratories (6); Baxa Corp., Sub. of Cook Group, Inc. (5); Gil-Med Industries C/O Kegan & Kegan, Ltd. (4); Williams Medical Co. (4).
Have KPE devices been recalled?
Yes: 62 product recalls across 16 recall events; the most recent began 2024-10-09.
Next steps
- Run an FDA pathway report with predicate devices for product code KPE
- Run a recall and safety report across every KPE manufacturer
- Watch product code KPE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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