Incubator, Neonatal Transport
The Neonatal Transport Incubator is a portable enclosed environment designed to maintain controlled temperature, humidity, and oxygen levels for critically ill or premature newborns during transport between healthcare facilities or within a hospital. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FPL, regulated under 21 CFR 880.5410 in the General Hospital specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- FPL
- Device Class
- FDA class 2
- Regulation Number
- 880.5410
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 25 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K220742 | NxtGen Infant Transport Incubator | Jul 15, 2022 | Substantially Equivalent | International Biomedical |
| K161918 | SREE MRI Transport Incubator | Mar 03, 2017 | Substantially Equivalent | Advanced Imaging Research Dba Sree Medical Systems |
| K141565 | GLOBE-TROTTER GT5400 | Sep 10, 2014 | Substantially Equivalent | Draeger Medical Systems, Inc. |
| K123937 | ATOM TRANSCAPSULE V-707 | May 23, 2013 | Substantially Equivalent | Atom Medical Corporation |
| K103525 | A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX | May 11, 2011 | Substantially Equivalent | International Biomedical, Ltd. |
| K103523 | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | May 11, 2011 | Substantially Equivalent | International Biomedical, Ltd. |
| K103527 | AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | Apr 15, 2011 | Substantially Equivalent | International Biomedical, Ltd. |
| K103524 | VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | Apr 15, 2011 | Substantially Equivalent | International Biomedical, Ltd. |
| K081399 | AVIATOR TRANSPORT INCUBATOR | Jun 06, 2008 | Substantially Equivalent | International Biomedical, Ltd. |
| K061071 | V-808 ATOM TRANSCAPSULE | Aug 29, 2006 | Substantially Equivalent | Atom Medical, Inc. |
| K062052 | LMT NOMAG IC 3.0 | Jul 31, 2006 | Substantially Equivalent | Lmt Lammers Medical Technology GmbH |
| K033565 | LMT NOMAG IC 1,5 | Nov 21, 2003 | Substantially Equivalent | Lmt Lammers Medical Technology GmbH |
| K031096 | MODIFICATION TO TRANSPORT INCUBATOR 185 | Jun 24, 2003 | Substantially Equivalent | International Biomedics, Inc. |
| K022876 | MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 | Sep 11, 2002 | Substantially Equivalent | International Biomedical, Inc. |
| K001019 | TI500 GLOBE-TROTTER TRANSPORT SYSTEM | Apr 27, 2000 | Substantially Equivalent | Hill-Rom Air-Shields |
| K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR | Jun 10, 1994 | Substantially Equivalent | Air-Shields, Inc. |
| K932417 | FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT | Sep 09, 1993 | Substantially Equivalent | Ferno-Washington, Inc. |
| K931346 | FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT | Aug 25, 1993 | Substantially Equivalent | Ferno |
| K893624 | PREEMICARE MODEL 2500 TRANSPORT WARMER | Sep 27, 1989 | Substantially Equivalent | Preemicare Corp. |
| K854065 | INFANT LIFE SUPPORT MODULE-20 | Jan 16, 1986 | Substantially Equivalent | Intl. Biomedics, Inc. |
| K850496 | TRANSPORT INCUBATOR 185 | May 23, 1985 | Substantially Equivalent | Airborne Life Support Systems, Inc. |
| K831028 | TI-1000 TRANSPORT INCUBATOR | May 09, 1983 | Substantially Equivalent | Narco Scientific |
| K790689 | REVISED BATTERY CHARGER | May 29, 1979 | Substantially Equivalent | Vickers America Medical Corp. |
| K790551 | TRANSPORT INCUBATOR | Apr 24, 1979 | Substantially Equivalent | Narco Air-Shields |
| K780964 | TRANSPORT INCUBATOR | Jul 27, 1978 | Substantially Equivalent | Cavitron Corp. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.