FDA product code FMT: Warmer, Infant Radiant
FMT is the FDA product code for warmer, infant radiant. It is a Class II device, regulated under 21 CFR 880.5130 and reviewed by the General Hospital panel. FDA has cleared 92 510(k) submissions under FMT, 3 in the last five years, from 51 different applicants. The average 510(k) review took 159 days (median 108); 57 days on average over the last three years. FDA has posted 34 recalls for FMT devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Warmer, Infant Radiant |
| Device class | Class II |
| Regulation | 21 CFR 880.5130 |
| 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 FMT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 276 |
| 2020 | 2 | 146 |
| 2021 | 1 | 241 |
| 2022 | 1 | 114 |
| 2023 | 1 | 118 |
| 2025 | 1 | 57 |
Top FMT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ohmeda Medical | 10 | 2013-02-05 |
| Contour Medical Technology, Inc. | 6 | 1996-04-04 |
| Air-Shields, Inc. | 5 | 1995-05-03 |
| Hill-Rom, Inc. | 4 | 1998-01-05 |
| Fisher & Paykel Electronics , Ltd. | 4 | 1997-10-30 |
46 more applicants have FMT clearances. See the full list in Caduvo.
Most recent FMT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243606 | Draeger Medical Systems, Inc. | Babyroo TN300 | 2025-01-17 | 57 |
| K230278 | Draeger Medical Systems, Inc. | Babyroo TN300 | 2023-05-30 | 118 |
| K213551 | Datex Ohmeda, Inc. | Giraffe Omnibed Carestation CS1 | 2022-03-02 | 114 |
| K201628 | GE Healthcare | Panda iRes Warmer, Giraffe Warmer | 2021-02-12 | 241 |
| K200319 | Deroyal Industries, Inc. | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable | 2020-04-02 | 55 |
Recalls for FMT devices
34 product recalls in 17 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-08-09.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 4 |
| 2019 | 6 |
| 2023 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code FMT?
FMT is the FDA product code for warmer, infant radiant. It is a Class II device, regulated under 21 CFR 880.5130 and reviewed by the General Hospital panel.
What device class is FMT?
Class II, regulation 21 CFR 880.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code FMT?
Across 92 cleared submissions the average was 159 days from receipt to decision (median 108).
Which companies have the most FMT clearances?
Ohmeda Medical (10); Contour Medical Technology, Inc. (6); Air-Shields, Inc. (5); Hill-Rom, Inc. (4); Fisher & Paykel Electronics , Ltd. (4).
Have FMT devices been recalled?
Yes: 34 product recalls across 17 recall events; the most recent began 2024-08-09.
Next steps
- Run an FDA pathway report with predicate devices for product code FMT
- Run a recall and safety report across every FMT manufacturer
- Watch product code FMT 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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