Product code FPL
- Device name
- Incubator, Neonatal Transport
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5410
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220742 | NxtGen Infant Transport Incubator | International Biomedical | 2022-07-15 |
| K161918 | SREE MRI Transport Incubator | Advanced Imaging Research Dba Sree Medical Systems | 2017-03-03 |
| K141565 | GLOBE-TROTTER GT5400 | Draeger Medical Systems, Inc. | 2014-09-10 |
| K123937 | ATOM TRANSCAPSULE V-707 | Atom Medical Corporation | 2013-05-23 |
| K103523 | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | International Biomedical, Ltd. | 2011-05-11 |
| K103525 | A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX | International Biomedical, Ltd. | 2011-05-11 |
| K103524 | VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | International Biomedical, Ltd. | 2011-04-15 |
| K103527 | AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | International Biomedical, Ltd. | 2011-04-15 |
| K081399 | AVIATOR TRANSPORT INCUBATOR | International Biomedical, Ltd. | 2008-06-06 |
| K061071 | V-808 ATOM TRANSCAPSULE | Atom Medical, Inc. | 2006-08-29 |
| K062052 | LMT NOMAG IC 3.0 | Lmt Lammers Medical Technology GmbH | 2006-07-31 |
| K033565 | LMT NOMAG IC 1,5 | Lmt Lammers Medical Technology GmbH | 2003-11-21 |
| K031096 | MODIFICATION TO TRANSPORT INCUBATOR 185 | International Biomedics, Inc. | 2003-06-24 |
| K022876 | MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 | International Biomedical, Inc. | 2002-09-11 |
| K001019 | TI500 GLOBE-TROTTER TRANSPORT SYSTEM | Hill-Rom Air-Shields | 2000-04-27 |
| K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR | Air-Shields, Inc. | 1994-06-10 |
| K932417 | FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT | Ferno-Washington, Inc. | 1993-09-09 |
| K931346 | FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT | Ferno | 1993-08-25 |
| K893624 | PREEMICARE MODEL 2500 TRANSPORT WARMER | Preemicare Corp. | 1989-09-27 |
| K854065 | INFANT LIFE SUPPORT MODULE-20 | Intl. Biomedics, Inc. | 1986-01-16 |
| K850496 | TRANSPORT INCUBATOR 185 | Airborne Life Support Systems, Inc. | 1985-05-23 |
| K831028 | TI-1000 TRANSPORT INCUBATOR | Narco Scientific | 1983-05-09 |
| K790689 | REVISED BATTERY CHARGER | Vickers America Medical Corp. | 1979-05-29 |
| K790551 | TRANSPORT INCUBATOR | Narco Air-Shields | 1979-04-24 |
| K780964 | TRANSPORT INCUBATOR | Cavitron Corp. | 1978-07-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04049098061858 | Disposable Mechanical Ventilation Circuit | DRAEGER MEDICAL SYSTEMS, INC. | 2025-12-10 |
| 04049098041829 | Disposable Mechanical Ventilation Circuit | DRAEGER MEDICAL SYSTEMS, INC. | 2025-12-10 |
| B510A3158 | ADVANCED TRANSPORT INCUBATOR | ADVANCED INSTRUMENTATIONS, INC. | 2025-02-04 |
| 05055931111146 | Reusable Skin Temperature Probes | FLEXICARE MEDICAL LIMITED | 2023-07-27 |
| 05055931132042 | Disposable Skin Temperature Probes | FLEXICARE MEDICAL LIMITED | 2023-07-27 |
| 00865648000306 | Aviator Transport Incubator | INTERNATIONAL BIOMEDICAL, LTD. | 2023-06-20 |
| 00865648000320 | Voyager Infant Transport Incubator | INTERNATIONAL BIOMEDICAL, LTD. | 2023-06-20 |
| 00868406000099 | 185A+ Infant Incubator | INTERNATIONAL BIOMEDICAL, LTD. | 2023-06-20 |
| 00850018561020 | NxtGen Infant Transport Incubator | INTERNATIONAL BIOMEDICAL, LTD. | 2023-04-07 |
| 00850018561013 | NxtGen Infant Transport Incubator | INTERNATIONAL BIOMEDICAL, LTD. | 2022-10-27 |
| 04260486610575 | LMT nomag® IC 3.0 | LMT Medical Systems GmbH | 2020-08-23 |
| 04260486610568 | LMT nomag® IC 1.5 | LMT Medical Systems GmbH | 2020-08-23 |
| 00854401006327 | Reusable Skin Temperature Probes | FLEXICARE MEDICAL LIMITED | 2019-06-05 |
| 00854401006310 | Disposable Skin Temperature Probes | FLEXICARE MEDICAL LIMITED | 2018-12-11 |
| 04260486610032 | LMT nomag® IC 3.0 | LMT Medical Systems GmbH | 2017-06-14 |
| 04260486610018 | LMT nomag® IC 1.5 | LMT Medical Systems GmbH | 2016-12-23 |
| 00868406000037 | 185A+ Infant Incubator | INTERNATIONAL BIOMEDICAL, LTD. | 2016-09-27 |
| 00868406000020 | Voyager Infant Transport Incubator | INTERNATIONAL BIOMEDICAL, LTD. | 2016-09-27 |
| 00868406000013 | A750i Infant Incubator | INTERNATIONAL BIOMEDICAL, LTD. | 2016-09-27 |
| 00868406000006 | Aviator Transport Incubator | INTERNATIONAL BIOMEDICAL, LTD. | 2016-09-27 |
| 04942962608619 | Semi-Iris Access Port Cover(20 pcs/pkg) | ATOM MEDICAL CORPORATION | 2016-09-21 |
| 04942962613057 | V-707 with Power Pack(100-120V) | ATOM MEDICAL CORPORATION | 2016-09-21 |
| 04942962615228 | V-808 Main Unit Only(120 V) | ATOM MEDICAL CORPORATION | 2016-09-21 |
| 04942962603171 | Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TR | ATOM MEDICAL CORPORATION | 2016-09-21 |
| 04942962603058 | Oxygen Sensor For V-808 | ATOM MEDICAL CORPORATION | 2016-09-21 |
| 04049098000413 | Restraint strap, replacement, carton of 10 | DRAEGER MEDICAL SYSTEMS, INC. | 2015-10-24 |
| 04049098000208 | Isolette TI500 Transport Incubator | DRAEGER MEDICAL SYSTEMS, INC. | 2015-10-24 |
| 04049098000192 | TI500 Globetrotter Neonatal Transport System | DRAEGER MEDICAL SYSTEMS, INC. | 2015-10-24 |