FMT · Warmer, Infant Radiant
General Hospital · 21 CFR 880.5130 · Class 2
Overview
| Product Code | FMT |
|---|---|
| Device Name | Warmer, Infant Radiant |
| Regulation | 21 CFR 880.5130 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 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 | Babyroo TN300 | Draeger Medical Systems, Inc. | Jan 17, 2025 | SESE |
| K230278 | Babyroo TN300 | Draeger Medical Systems, Inc. | May 30, 2023 | SESE |
| K213551 | Giraffe Omnibed Carestation CS1 | Datex Ohmeda, Inc. | Mar 2, 2022 | SESE |
| K201628 | Panda iRes Warmer, Giraffe Warmer | GE Healthcare | Feb 12, 2021 | SESE |
| K200319 | 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 | Hydro-Temp Neonatal Skin Temperature Probe Cover | Deroyal Industries, Inc. | Jan 21, 2020 | SESE |
| K173516 | NuBorne Infant Warmer | International Biomedical | Aug 17, 2018 | SESE |
| K123309 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical | Feb 5, 2013 | SESE |
| K120642 | RESUSCITAIRE WITH AUTOBREATH | Draeger Medical Systems, Inc. | Nov 2, 2012 | SESE |
| K122267 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | Oct 2, 2012 | SESE |
| K121625 | LULLABY TM WARMER | Wipro GE Healthcare Private, Ltd. | Sep 14, 2012 | SESE |
| K120937 | SUNFLOWER WARNER | Atom Medical Corporation | Jul 6, 2012 | SESE |
| K102227 | INFA WARMER I | Atom Medical Corporation | Jan 21, 2011 | SESE |
| K101804 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | Jul 21, 2010 | SESE |
| K090697 | MODIFICATION TO: GIRAFFE AND PANDA WARMER | Ohmeda Medical | Apr 16, 2009 | SESE |
| K072157 | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | Ohmeda Medical | Aug 27, 2007 | SESE |
| K070377 | GIRAFFE AND PANDA WARMER | Ohmeda Medical | Jul 11, 2007 | SESE |
| K060461 | V-505 INFA WARMER | Atom Medical, Inc. | Apr 28, 2006 | SESE |
| K033040 | PHOENIX INFANT RADIANT WARMER, MODEL 100NWS | International Hospital Supply Co. | Dec 17, 2003 | SESE |
| K020966 | 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
