Cleared Traditional

VERSALET 7700 CARE CENTER (K053399) - FDA 510(k) Clearance

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

K053399 · Draeger Medical Infant Care, Inc. · General Hospital
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Aug 2006
Decision
241d
Days
Class 2
Risk

K053399 is an FDA 510(k) clearance for the VERSALET 7700 CARE CENTER. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Draeger Medical Infant Care, Inc. (Hatboro, US). The FDA issued a Cleared decision on August 4, 2006 after a review of 241 days - an extended review cycle.

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 Draeger Medical Infant Care, Inc. devices

Submission Details

510(k) Number K053399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2005
Decision Date August 04, 2006
Days to Decision 241 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 129d · This submission: 241d
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.

Regulatory Peers - FMZ Incubator, Neonatal

All 84
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K053399.
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K251663 · Datex-Ohmeda, Inc. · Oct 2025
mOm Essential Incubator (ME1)
K243437 · Mom Incubators Limited · Aug 2025
Giraffe Incubator Carestation CS1
K213553 · Datex-Ohmeda, Inc. · Mar 2022
Infant Incubator
K190494 · Ningbo David Medical Device Co., Ltd. · Nov 2019
Babyleo TN500
K182859 · Dragerwerk AG & CO Kgaa · Feb 2019