Cleared Traditional

K040910 - INFANT INCUBATOR, MODEL CHS-I1000

K040910 is an FDA 510(k) clearance for INFANT INCUBATOR, manufactured by Choong Wae Medical Corp.. The device is a Class 2 General Hospital device with product code FMZ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K040910 · Choong Wae Medical Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
13d
Days
Class 2
Risk

K040910 is an FDA 510(k) clearance for the INFANT INCUBATOR, MODEL CHS-I1000. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Choong Wae Medical Corp. (Marietta, US). The FDA issued a Cleared decision on April 21, 2004 after a review of 13 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K040910

510(k) Number K040910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2004
Decision Date April 21, 2004
Days to Decision 13 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 129d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FMZ Device Classification - Class 2, Special Controls

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 Consultant

Underwriters Laboratories, Inc.
CHAN YO WON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMZ Incubator, Neonatal

All 80
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K040910.
V-2200 INFANT INCUBATOR
K061856 · Atom Medical, Inc. · Sep 2006
VERSALET 7700 CARE CENTER
K053399 · Draeger Medical Infant Care, Inc. · Aug 2006
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K061280 · Neoforce Group, Inc. · Jun 2006
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
K040068 · Ohmeda Medical · Apr 2004
ISOLETTE INFANT INCUBATOR, MODEL C2000E
K031387 · Hill-Rom Manufacturing, Inc. · Aug 2003
V-2100G ADVANCED INFANT INCUBATOR
K021809 · Atom Medical Corp · Jul 2002

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K040910 · INFANT INCUBATOR, MODEL CHS-I1000
Download PDF FDA Summary Choong Wae Medical Co…