Incubator, Neonatal Transport
FDA product code FPL · Class II (moderate risk) · 21 CFR 880.5410 · General Hospital
25510(k) clearances
0PMA approvals
1recalls
Manufacturers
- International Biomedical 7
- Atom Medical Corporation 2
- Lmt Lammers Medical Technology GmbH 2
- Ferno-Washington Inc 1
- Advanced Imaging Research Dba Sree Medical Systems 1
- Draeger Medical Systems, Inc. 1
- International Biomedics, Inc. 1
- Hill-Rom Air-Shields 1
- Air-Shields, Inc. 1
- Cavitron Corp. 1
- Ferno 1
- Preemicare Corp. 1
- Intl. Biomedics, Inc. 1
- Airborne Life Support Systems, Inc. 1
- Narco Scientific 1
- Vickers America Medical Corp. 1
- Narco Air-Shields 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220742 | NxtGen Infant Transport IncubatorFPL · Traditional | International Biomedical | 07/15/2022SE |
| K161918 | SREE MRI Transport IncubatorFPL · Traditional | Advanced Imaging Research Dba Sree Medical Systems | 03/03/2017SE |
| K141565 | Globe-Trotter GT5400FPL · Traditional | Draeger Medical Systems, Inc. | 09/10/2014SE |
| K123937 | Atom Transcapsule V-707FPL · Traditional | Atom Medical Corporation | 05/23/2013SE |
| K103525 | A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with Nellor…FPL · Special | International Biomedical, Ltd. | 05/11/2011SE |
| K103523 | 185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with Nellcor…FPL · Special | International Biomedical, Ltd. | 05/11/2011SE |
| K103527 | Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with…FPL · Special | International Biomedical, Ltd. | 04/15/2011SE |
| K103524 | Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with…FPL · Special | International Biomedical, Ltd. | 04/15/2011SE |
| K081399 | Aviator Transport IncubatorFPL · Special | International Biomedical, Ltd. | 06/06/2008SE |
| K061071 | V-808 Atom TranscapsuleFPL · Traditional | Atom Medical, Inc. | 08/29/2006SE |
| K062052 | LMT Nomag Ic 3.0FPL · Traditional | Lmt Lammers Medical Technology GmbH | 07/31/2006SE |
| K033565 | LMT Nomag Ic 1,5FPL · Abbreviated | Lmt Lammers Medical Technology GmbH | 11/21/2003SE |
| K031096 | Modification to Transport Incubator 185FPL · Special | International Biomedics, Inc. | 06/24/2003SE |
| K022876 | Modification to Infant Life Support MODULE-20FPL · Special | International Biomedical, Inc. | 09/11/2002SE |
| K001019 | TI500 Globe-Trotter Transport SystemFPL · Traditional | Hill-Rom Air-Shields | 04/27/2000SE |
| K941106 | Model TI500 Isolette Infant IncubatorFPL · Traditional | Air-Shields, Inc. | 06/10/1994SE |
| K932417 | Ferno Washington Incubator Transporter, Mod. 35-ITFPL · Traditional | Ferno-Washington, Inc. | 09/09/1993SE |
| K931346 | Ferno-Washington Incubator Transporter,# 29-ITFPL · Traditional | Ferno | 08/25/1993SE |
| K893624 | Preemicare Model 2500 Transport WarmerFPL · Traditional | Preemicare Corp. | 09/27/1989SE |
| K854065 | Infant Life Support MODULE-20FPL · Traditional | Intl. Biomedics, Inc. | 01/16/1986SE |
| K850496 | Transport Incubator 185FPL · Traditional | Airborne Life Support Systems, Inc. | 05/23/1985SE |
| K831028 | TI-1000 Transport IncubatorFPL · Traditional | Narco Scientific | 05/09/1983SE |
| K790689 | Revised Battery ChargerFPL · Traditional | Vickers America Medical Corp. | 05/29/1979SE |
| K790551 | Transport IncubatorFPL · Traditional | Narco Air-Shields | 04/24/1979SE |
| K780964 | Transport IncubatorFPL · Traditional | Cavitron Corp. | 07/27/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1365-2022 Class II | Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal…The firm has initiated this recall to replace component on devices distributed containing a component within… | Draeger Medical Systems, Inc. | 05/20/2022Open, Classified |