INFANT WARMER SYSTEM— 510(k) K963058

Clearance details

Applicant

Ohmeda Medical

Product code

Code FMT

Device class

Class 2

Regulation

21 CFR 880.5130

Advisory panel

General Hospital

Date received

1996-08-06

Decision date

1996-10-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Columbia, MD, US

• K243606 — Babyroo TN3002025-01-17
• K230278 — Babyroo TN3002023-05-30
• K213551 — Giraffe Omnibed Carestation CS12022-03-02
• K201628 — Panda iRes Warmer, Giraffe Warmer2021-02-12
• K200319 — HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable2020-04-02

• K123309 — GIRAFFE AND PANDA WARMERS2013-02-05
• K101778 — GIRAFFE INCUBATOR2010-07-21
• K101788 — GIRAFFE OMNIBED2010-07-21
• K090697 — MODIFICATION TO: GIRAFFE AND PANDA WARMER2009-04-16
• K072157 — MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)2007-08-27

Death

4

Malfunction

3,074

Total

3,078

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2323-2017 — Infant Warmer System (IWS)Class II·Terminated·GE Healthcare, LLC·20170505
• Z-1511-2017 — IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat to smoothen the transition from the uterus to the external environment. They fulfill the same purpose of neonatal incubators but they may be preferred over incubators when total access to the patient is needed or desirable (e.g., surgical procedures, extracorporeal membrane oxygenation, frequent resuscitation, etc.). Most infant radiant warmers can be used in two operating modes: 1. Manual: The clinician sets the appropriate heater output for maintaining the desired patient temperature. The heater output is initially selected based on the clinician s training and experience and then is adjusted based on the patients needs and clinical status. 2. Servo: The clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to the controller of the infant radiant warmer. The controller then adjusts the heater output to maintain the patient temperature at the set value. These adjustments to the heater output are made in such a way to gradually change the patient s temperature while minimizing overshooting and patient stress. Infant radiant warmers have alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient s temperature from the set value. Infant radiant warmers may incorporate other features, such as phototherapy, observation light, tilting of the bed, and data output to remote monitors or nurse call systemsClass II·Terminated·Ohmeda Medical·20161118
• Z-1015-2017 — Infant Warmer System (IWS)Class II·Terminated·GE Healthcare, LLC·20160804

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K963058.