FDA product code FMZ: Incubator, Neonatal
FMZ is the FDA product code for incubator, neonatal. It is a Class II device, regulated under 21 CFR 880.5400 and reviewed by the General Hospital panel. FDA has cleared 86 510(k) submissions under FMZ, 5 in the last five years, from 46 different applicants. The average 510(k) review took 136 days (median 90); 217 days on average over the last three years. FDA has posted 43 recalls for FMZ devices, 16 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Incubator, Neonatal |
| Device class | Class II |
| Regulation | 21 CFR 880.5400 |
| 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 FMZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 259 |
| 2018 | 2 | 151 |
| 2019 | 2 | 202 |
| 2022 | 1 | 114 |
| 2025 | 2 | 214 |
| 2026 | 2 | 220 |
Compare with all 510(k) review times · Search every FMZ clearance
Top FMZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ohmeda Medical | 15 | 2010-07-21 |
| Air-Shields, Inc. | 7 | 1996-07-30 |
| Air-Shields Vickers, Inc. | 6 | 1993-03-18 |
| Vickers America Medical Corp. | 4 | 1982-01-28 |
| Datex-Ohmeda, Inc. | 3 | 2026-07-28 |
41 more applicants have FMZ clearances. See the full list in Caduvo.
Most recent FMZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260326 | Datex-Ohmeda, Inc. | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | 2026-07-28 | 179 |
| K251619 | Drägerwerk AG & Co. KGaA | Babyleo TN500 | 2026-02-13 | 262 |
| K251663 | Datex-Ohmeda, Inc. | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | 2025-10-22 | 145 |
| K243437 | Mom Incubators Limited | mOm Essential Incubator (ME1) | 2025-08-14 | 282 |
| K213553 | Datex Ohmeda, Inc. | Giraffe Incubator Carestation CS1 | 2022-03-02 | 114 |
Recalls for FMZ devices
43 product recalls in 22 recall events; 16 initiated in the last five years and 15 still open. Most recent: 2026-05-01.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2019 | 1 |
| 2020 | 3 |
| 2021 | 1 |
| 2023 | 11 |
| 2024 | 2 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code FMZ?
FMZ is the FDA product code for incubator, neonatal. It is a Class II device, regulated under 21 CFR 880.5400 and reviewed by the General Hospital panel.
What device class is FMZ?
Class II, regulation 21 CFR 880.5400. Typical premarket route: 510(k).
How long does a 510(k) take for product code FMZ?
Across 86 cleared submissions the average was 136 days from receipt to decision (median 90).
Which companies have the most FMZ clearances?
Ohmeda Medical (15); Air-Shields, Inc. (7); Air-Shields Vickers, Inc. (6); Vickers America Medical Corp. (4); Datex-Ohmeda, Inc. (3).
Have FMZ devices been recalled?
Yes: 43 product recalls across 22 recall events; the most recent began 2026-05-01.
Next steps
- Run an FDA pathway report with predicate devices for product code FMZ
- Run a recall and safety report across every FMZ manufacturer
- Watch product code FMZ 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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