FDA product code LHB: Timer, Apgar
LHB is the FDA product code for timer, apgar. It is a Class I device, regulated under 21 CFR 880.2930 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under LHB, from 2 different applicants. The average 510(k) review took 44 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Timer, Apgar |
| Device class | Class I |
| Regulation | 21 CFR 880.2930 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every LHB clearance
Top LHB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medela, Inc. | 1 | 1984-01-10 |
| Pt&E | 1 | 1981-07-09 |
Most recent LHB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K834129 | Medela, Inc. | MEDELA APGAR TIMER | 1984-01-10 | 41 |
| K811424 | Pt&E | ELECTRONIC APGAR TIMER | 1981-07-09 | 48 |
Recalls for LHB devices
openFDA lists no recalls for product code LHB.
Frequently asked questions
What is FDA product code LHB?
LHB is the FDA product code for timer, apgar. It is a Class I device, regulated under 21 CFR 880.2930 and reviewed by the General Hospital panel.
What device class is LHB?
Class I, regulation 21 CFR 880.2930. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LHB?
Across 2 cleared submissions the average was 44 days from receipt to decision (median 44).
Which companies have the most LHB clearances?
Medela, Inc. (1); Pt&E (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LHB
- Run a recall and safety report across every LHB manufacturer
- Watch product code LHB 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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