Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5410](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5410) → FPL — Incubator, Neonatal Transport # FPL · Incubator, Neonatal Transport _General Hospital · 21 CFR 880.5410 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL ## Overview - **Product Code:** FPL - **Device Name:** Incubator, Neonatal Transport - **Regulation:** [21 CFR 880.5410](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5410) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K220742.md) | NxtGen Infant Transport Incubator | International Biomedical | Jul 15, 2022 | SESE | | [K161918](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K161918.md) | SREE MRI Transport Incubator | Advanced Imaging Research Dba Sree Medical Systems | Mar 3, 2017 | SESE | | [K141565](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K141565.md) | GLOBE-TROTTER GT5400 | Draeger Medical Systems, Inc. | Sep 10, 2014 | SESE | | [K123937](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K123937.md) | ATOM TRANSCAPSULE V-707 | Atom Medical Corporation | May 23, 2013 | SESE | | [K103525](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K103525.md) | A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX | International Biomedical, Ltd. | May 11, 2011 | SESE | | [K103523](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K103523.md) | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | International Biomedical, Ltd. | May 11, 2011 | SESE | | [K103527](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K103527.md) | AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | International Biomedical, Ltd. | Apr 15, 2011 | SESE | | [K103524](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K103524.md) | VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | International Biomedical, Ltd. | Apr 15, 2011 | SESE | | [K081399](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K081399.md) | AVIATOR TRANSPORT INCUBATOR | International Biomedical, Ltd. | Jun 6, 2008 | SESE | | [K061071](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K061071.md) | V-808 ATOM TRANSCAPSULE | Atom Medical, Inc. | Aug 29, 2006 | SESE | | [K062052](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K062052.md) | LMT NOMAG IC 3.0 | Lmt Lammers Medical Technology GmbH | Jul 31, 2006 | SESE | | [K033565](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K033565.md) | LMT NOMAG IC 1,5 | Lmt Lammers Medical Technology GmbH | Nov 21, 2003 | SESE | | [K031096](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K031096.md) | MODIFICATION TO TRANSPORT INCUBATOR 185 | International Biomedics, Inc. | Jun 24, 2003 | SESE | | [K022876](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K022876.md) | MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 | International Biomedical, Inc. | Sep 11, 2002 | SESE | | [K001019](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K001019.md) | TI500 GLOBE-TROTTER TRANSPORT SYSTEM | Hill-Rom Air-Shields | Apr 27, 2000 | SESE | | [K941106](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K941106.md) | MODEL TI500 ISOLETTE INFANT INCUBATOR | Air-Shields, Inc. | Jun 10, 1994 | SESE | | [K932417](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K932417.md) | FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT | Ferno-Washington, Inc. | Sep 9, 1993 | SESE | | [K931346](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K931346.md) | FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT | Ferno | Aug 25, 1993 | SESE | | [K893624](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K893624.md) | PREEMICARE MODEL 2500 TRANSPORT WARMER | Preemicare Corp. | Sep 27, 1989 | SESE | | [K854065](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL/K854065.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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