Isolette Incubator
FDA 510(k) K781876 · Air-Shields, Inc.
510(k) numberK781876
Submission
- Device name
- Isolette Incubator
- Applicant
- Air-Shields, Inc.
Mchenry, IL, US - Received
- November 2, 1978
- Decision date
- December 7, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMZ – Incubator, Neonatal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5400
- Specialty
- General Hospital
Other 510(k)s with product code FMZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | Datex-Ohmeda, Inc. | 07/28/2026SE |
| K251619 | Babyleo TN500FMZ · Traditional | Drägerwerk AG & Co. KGaA | 02/13/2026SE |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | Datex-Ohmeda, Inc. | 10/22/2025SE |
| K243437 | mOm Essential Incubator (ME1)FMZ · Traditional | Mom Incubators Limited | 08/14/2025SE |
| K213553 | Giraffe Incubator Carestation CS1FMZ · Traditional | Datex Ohmeda, Inc. | 03/02/2022SE |
| K190494 | Infant IncubatorFMZ · Traditional | Ningbo David Medical Device Co., Ltd. | 11/25/2019SE |
| K182859 | Babyleo TN500FMZ · Special | Dragerwerk AG & CO Kgaa | 02/22/2019SE |
| K182977 | Isolette 8000 PlusFMZ · Special | Draeger Medical Systems, Inc. | 11/21/2018SE |
| K172154 | Isolette 8000 plusFMZ · Traditional | Draeger Medical Sytems, Inc. | 04/19/2018SE |
| K162821 | Babyleo TN500FMZ · Traditional | Draegerwerk AG & CO Kgaa | 06/23/2017SE |
More from Draegerwerk AG & CO Kgaa
| 510(k) | Device | Decision |
|---|---|---|
| K974248 | Watchchild Obsterical Patient Data Management SystemHGM · Traditional | 10/07/1998SE |
| K972309 | JM-102 Jaundice MeterMQM · Traditional | 09/22/1998SE |
| K971256 | Duo-Lite Phototherapy SystemLBI · Traditional | 09/24/1997SE |
| K960980 | Isolette Infant IncubatorFMZ · Traditional | 07/30/1996SE |
| K924709 | Satcare Oxygen Controller/Monitor W/ Pulse OximeteKLK · Traditional | 01/17/1996SE |
| K940951 | RW Resucitaire Infant Radiant WarmerFMT · Traditional | 05/03/1995SE |
| K940975 | C450/C400 Infant IncubatorsFMZ · Traditional | 06/23/1994SE |
| K941106 | Model TI500 Isolette Infant IncubatorFPL · Traditional | 06/10/1994SE |
| K924170 | Isolette Incubator Humidity MeterFMZ · Traditional | 02/05/1993SE |
| K922150 | Examination LampKZF · Traditional | 07/21/1992SE |
Questions and answers
When was Isolette Incubator cleared by the FDA?
Isolette Incubator (K781876) received a 510(k) decision of Substantially Equivalent on December 7, 1978, 35 days after the submission was received.
What is the product code of K781876?
The FDA product code is FMZ – Incubator, Neonatal, a Class II (moderate risk) device regulated under 21 CFR 880.5400.