FDA product code LPP: Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
LPP is the FDA product code for monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia. It is a Class II device, regulated under 21 CFR 868.2500 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under LPP, from 2 different applicants. The average 510(k) review took 120 days (median 120). FDA has posted 1 recall for LPP devices.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia |
| Device class | Class II |
| Regulation | 21 CFR 868.2500 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LPP clearance
Top LPP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Radiometer Medical A/S | 1 | 2000-12-07 |
| Mennen Medical, Inc. | 1 | 1989-02-17 |
Most recent LPP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K001866 | Radiometer Medical A/S | TCM400 | 2000-12-07 | 170 |
| K885079 | Mennen Medical, Inc. | HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275 | 1989-02-17 | 71 |
Recalls for LPP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-11-27.
Frequently asked questions
What is FDA product code LPP?
LPP is the FDA product code for monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia. It is a Class II device, regulated under 21 CFR 868.2500 and reviewed by the Anesthesiology panel.
What device class is LPP?
Class II, regulation 21 CFR 868.2500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LPP?
Across 2 cleared submissions the average was 120 days from receipt to decision (median 120).
Which companies have the most LPP clearances?
Radiometer Medical A/S (1); Mennen Medical, Inc. (1).
Have LPP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-11-27.
Next steps
- Run an FDA pathway report with predicate devices for product code LPP
- Run a recall and safety report across every LPP manufacturer
- Watch product code LPP 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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