Cleared Traditional

Infant Incubator (K190494) - FDA 510(k) Clearance

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

K190494 · Ningbo David Medical Device Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
270d
Days
Class 2
Risk

K190494 is an FDA 510(k) clearance for the Infant Incubator. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Ningbo David Medical Device Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on November 25, 2019 after a review of 270 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 Ningbo David Medical Device Co., Ltd. devices

Submission Details

510(k) Number K190494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2019
Decision Date November 25, 2019
Days to Decision 270 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
141d slower than avg
Panel avg: 129d · This submission: 270d
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 K190494.
Babyleo TN500
K251619 · Dr?gerwerk AG & Co KGaA · Feb 2026
Giraffe OmniBed Carestation (CS1)
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
Babyleo TN500
K182859 · Dragerwerk AG & CO Kgaa · Feb 2019
Isolette 8000 Plus
K182977 · Draeger Medical Systems, Inc. · Nov 2018