FDA product code FPL: Incubator, Neonatal Transport
FPL is the FDA product code for incubator, neonatal transport. It is a Class II device, regulated under 21 CFR 880.5410 and reviewed by the General Hospital panel. FDA has cleared 25 510(k) submissions under FPL, 1 in the last five years, from 20 different applicants. The average 510(k) review took 95 days (median 104). FDA has posted 1 recall for FPL devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Incubator, Neonatal Transport |
| Device class | Class II |
| Regulation | 21 CFR 880.5410 |
| 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 FPL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 233 |
| 2022 | 1 | 123 |
Compare with all 510(k) review times · Search every FPL clearance
Top FPL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| International Biomedical, Ltd. | 5 | 2011-05-11 |
| Lmt Lammers Medical Technology GmbH | 2 | 2006-07-31 |
| International Biomedical | 1 | 2022-07-15 |
| Advanced Imaging Research Dba Sree Medical Systems | 1 | 2017-03-03 |
| Draeger Medical Systems, Inc. | 1 | 2014-09-10 |
15 more applicants have FPL clearances. See the full list in Caduvo.
Most recent FPL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220742 | International Biomedical | NxtGen Infant Transport Incubator | 2022-07-15 | 123 |
| K161918 | Advanced Imaging Research Dba Sree Medical Systems | SREE MRI Transport Incubator | 2017-03-03 | 233 |
| K141565 | Draeger Medical Systems, Inc. | GLOBE-TROTTER GT5400 | 2014-09-10 | 90 |
| K123937 | Atom Medical Corporation | ATOM TRANSCAPSULE V-707 | 2013-05-23 | 154 |
| K103523 | International Biomedical, Ltd. | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | 2011-05-11 | 161 |
Recalls for FPL devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-20.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code FPL?
FPL is the FDA product code for incubator, neonatal transport. It is a Class II device, regulated under 21 CFR 880.5410 and reviewed by the General Hospital panel.
What device class is FPL?
Class II, regulation 21 CFR 880.5410. Typical premarket route: 510(k).
How long does a 510(k) take for product code FPL?
Across 25 cleared submissions the average was 95 days from receipt to decision (median 104).
Which companies have the most FPL clearances?
International Biomedical, Ltd. (5); Lmt Lammers Medical Technology GmbH (2); International Biomedical (1); Advanced Imaging Research Dba Sree Medical Systems (1); Draeger Medical Systems, Inc. (1).
Have FPL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-05-20.
Next steps
- Run an FDA pathway report with predicate devices for product code FPL
- Run a recall and safety report across every FPL manufacturer
- Watch product code FPL 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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