FDA product code LHF: Warmer, Microwave, Infusion Fluid
LHF is the FDA product code for warmer, microwave, infusion fluid. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under LHF, from 2 different applicants. The average 510(k) review took 22 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Warmer, Microwave, Infusion Fluid |
| Device class | Class II |
| Regulation | 21 CFR 880.5725 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LHF clearance
Top LHF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Downs Surgical , Ltd. | 1 | 1981-07-10 |
| Travenol Laboratories, S.A. | 1 | 1981-07-10 |
Most recent LHF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K811726 | Downs Surgical , Ltd. | LEKSELL STEREOACTIC SYSTEM | 1981-07-10 | 22 |
| K811724 | Travenol Laboratories, S.A. | 2M 9810 MICROWAVE OVEN | 1981-07-10 | 22 |
Recalls for LHF devices
openFDA lists no recalls for product code LHF.
Frequently asked questions
What is FDA product code LHF?
LHF is the FDA product code for warmer, microwave, infusion fluid. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel.
What device class is LHF?
Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code LHF?
Across 2 cleared submissions the average was 22 days from receipt to decision (median 22).
Which companies have the most LHF clearances?
Downs Surgical , Ltd. (1); Travenol Laboratories, S.A. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LHF
- Run a recall and safety report across every LHF manufacturer
- Watch product code LHF 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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