Cleared Traditional

Giraffe Omnibed Carestation CS1 (K213551) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213551 · Datex-Ohmeda, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
114d
Days
Class 2
Risk

K213551 is an FDA 510(k) clearance for the Giraffe Omnibed Carestation CS1. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Datex-Ohmeda, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on March 2, 2022 after a review of 114 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5130 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Datex-Ohmeda, Inc. devices

Submission Details

510(k) Number K213551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2021
Decision Date March 02, 2022
Days to Decision 114 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 129d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMT Warmer, Infant Radiant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMT Warmer, Infant Radiant

All 91
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K213551.
Babyroo TN300
K243606 · Draeger Medical Systems, Inc. · Jan 2025
Babyroo TN300
K230278 · Draeger Medical Systems, Inc. · May 2023
Panda iRes Warmer, Giraffe Warmer
K201628 · Ge Healthcare · Feb 2021
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
K200319 · Deroyal Industries, Inc. · Apr 2020
Hydro-Temp Neonatal Skin Temperature Probe Cover
K191425 · Deroyal Industries, Inc. · Jan 2020
NuBorne Infant Warmer
K173516 · International Biomedical · Aug 2018