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 880.5130](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5130) → FMT — Warmer, Infant Radiant # FMT · Warmer, Infant Radiant _General Hospital · 21 CFR 880.5130 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT ## Overview - **Product Code:** FMT - **Device Name:** Warmer, Infant Radiant - **Regulation:** [21 CFR 880.5130](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5130) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## Identification The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit. ## Classification Rationale Class II (Special Controls) ## Special Controls *Classification.* Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer; (2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and (3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device. ## Recent Cleared Devices (20 of 92) Showing 20 most recent of 92 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243606](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K243606.md) | Babyroo TN300 | Draeger Medical Systems, Inc. | Jan 17, 2025 | SESE | | [K230278](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K230278.md) | Babyroo TN300 | Draeger Medical Systems, Inc. | May 30, 2023 | SESE | | [K213551](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K213551.md) | Giraffe Omnibed Carestation CS1 | Datex Ohmeda, Inc. | Mar 2, 2022 | SESE | | [K201628](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K201628.md) | Panda iRes Warmer, Giraffe Warmer | GE Healthcare | Feb 12, 2021 | SESE | | [K200319](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K200319.md) | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable | Deroyal Industries, Inc. | Apr 2, 2020 | SESE | | [K191425](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K191425.md) | Hydro-Temp Neonatal Skin Temperature Probe Cover | Deroyal Industries, Inc. | Jan 21, 2020 | SESE | | [K173516](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K173516.md) | NuBorne Infant Warmer | International Biomedical | Aug 17, 2018 | SESE | | [K123309](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K123309.md) | GIRAFFE AND PANDA WARMERS | Ohmeda Medical | Feb 5, 2013 | SESE | | [K120642](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K120642.md) | RESUSCITAIRE WITH AUTOBREATH | Draeger Medical Systems, Inc. | Nov 2, 2012 | SESE | | [K122267](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K122267.md) | GIRAFFE AND PANDA WARMERS | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | Oct 2, 2012 | SESE | | [K121625](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K121625.md) | LULLABY TM WARMER | Wipro GE Healthcare Private, Ltd. | Sep 14, 2012 | SESE | | [K120937](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K120937.md) | SUNFLOWER WARNER | Atom Medical Corporation | Jul 6, 2012 | SESE | | [K102227](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K102227.md) | INFA WARMER I | Atom Medical Corporation | Jan 21, 2011 | SESE | | [K101804](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K101804.md) | GIRAFFE AND PANDA WARMERS | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | Jul 21, 2010 | SESE | | [K090697](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K090697.md) | MODIFICATION TO: GIRAFFE AND PANDA WARMER | Ohmeda Medical | Apr 16, 2009 | SESE | | [K072157](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K072157.md) | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | Ohmeda Medical | Aug 27, 2007 | SESE | | [K070377](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K070377.md) | GIRAFFE AND PANDA WARMER | Ohmeda Medical | Jul 11, 2007 | SESE | | [K060461](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K060461.md) | V-505 INFA WARMER | Atom Medical, Inc. | Apr 28, 2006 | SESE | | [K033040](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K033040.md) | PHOENIX INFANT RADIANT WARMER, MODEL 100NWS | International Hospital Supply Co. | Dec 17, 2003 | SESE | | [K020966](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT/K020966.md) | RPI REPLACEMENT HEATING ELEMENTS | Replacement Parts Industries, Inc. | Jun 13, 2002 | SESE | ## Top Applicants - Ohmeda Medical — 10 clearances - Contour Medical Technology, Inc. — 6 clearances - Air-Shields, Inc. — 5 clearances - Fisher & Paykel Electronics , Ltd. — 4 clearances - Gempco, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMT) **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. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com