FPL · Incubator, Neonatal Transport
General Hospital · 21 CFR 880.5410 · Class 2
Overview
| Product Code | FPL |
|---|---|
| Device Name | Incubator, Neonatal Transport |
| Regulation | 21 CFR 880.5410 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 25)
Showing 20 most recent of 25 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220742 | NxtGen Infant Transport Incubator | International Biomedical | Jul 15, 2022 | SESE |
| K161918 | SREE MRI Transport Incubator | Advanced Imaging Research Dba Sree Medical Systems | Mar 3, 2017 | SESE |
| K141565 | GLOBE-TROTTER GT5400 | Draeger Medical Systems, Inc. | Sep 10, 2014 | SESE |
| K123937 | ATOM TRANSCAPSULE V-707 | Atom Medical Corporation | May 23, 2013 | SESE |
| K103525 | A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX | International Biomedical, Ltd. | May 11, 2011 | SESE |
| K103523 | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | International Biomedical, Ltd. | May 11, 2011 | SESE |
| K103527 | AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | International Biomedical, Ltd. | Apr 15, 2011 | SESE |
| K103524 | VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | International Biomedical, Ltd. | Apr 15, 2011 | SESE |
| K081399 | AVIATOR TRANSPORT INCUBATOR | International Biomedical, Ltd. | Jun 6, 2008 | SESE |
| K061071 | V-808 ATOM TRANSCAPSULE | Atom Medical, Inc. | Aug 29, 2006 | SESE |
| K062052 | LMT NOMAG IC 3.0 | Lmt Lammers Medical Technology GmbH | Jul 31, 2006 | SESE |
| K033565 | LMT NOMAG IC 1,5 | Lmt Lammers Medical Technology GmbH | Nov 21, 2003 | SESE |
| K031096 | MODIFICATION TO TRANSPORT INCUBATOR 185 | International Biomedics, Inc. | Jun 24, 2003 | SESE |
| K022876 | MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 | International Biomedical, Inc. | Sep 11, 2002 | SESE |
| K001019 | TI500 GLOBE-TROTTER TRANSPORT SYSTEM | Hill-Rom Air-Shields | Apr 27, 2000 | SESE |
| K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR | Air-Shields, Inc. | Jun 10, 1994 | SESE |
| K932417 | FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT | Ferno-Washington, Inc. | Sep 9, 1993 | SESE |
| K931346 | FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT | Ferno | Aug 25, 1993 | SESE |
| K893624 | PREEMICARE MODEL 2500 TRANSPORT WARMER | Preemicare Corp. | Sep 27, 1989 | SESE |
| K854065 | INFANT LIFE SUPPORT MODULE-20 | Intl. Biomedics, Inc. | Jan 16, 1986 | SESE |
Top Applicants
- International Biomedical, Ltd. — 5 clearances
- Lmt Lammers Medical Technology GmbH — 2 clearances
- Advanced Imaging Research Dba Sree Medical Systems — 1 clearance
- Air-Shields, Inc. — 1 clearance
- Airborne Life Support Systems, Inc. — 1 clearance
