Cleared Traditional

K213553 - Giraffe Incubator Carestation CS1 (FDA 510(k) Clearance)

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

K213553 · Datex-Ohmeda, Inc. · General Hospital
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Mar 2022
Decision
114d
Days
Class 2
Risk

K213553 is an FDA 510(k) clearance for the Giraffe Incubator Carestation CS1. Classified as Incubator, Neonatal (product code FMZ), 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 880.5400 - 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 K213553 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
14d faster than avg
Panel avg: 128d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMZ Incubator, Neonatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5400
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.