Cleared Traditional

INFANT INCUBATOR (K132543) - FDA 510(k) Clearance

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

K132543 · Bistos Co., Ltd. · General Hospital
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Jul 2014
Decision
324d
Days
Class 2
Risk

K132543 is an FDA 510(k) clearance for the INFANT INCUBATOR. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Bistos Co., Ltd. (Ramsey, US). The FDA issued a Cleared decision on July 3, 2014 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bistos Co., Ltd. devices

Submission Details

510(k) Number K132543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2013
Decision Date July 03, 2014
Days to Decision 324 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
195d slower than avg
Panel avg: 129d · This submission: 324d
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 24
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K132543.
Babyleo TN500
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Isolette 8000 plus
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GIRAFFE INCUBATOR
K101778 · Ohmeda Medical · Jul 2010
GIRAFFE OMNIBED
K101788 · Ohmeda Medical · Jul 2010
OHMEDA MEDICAL GIRAFFE OMNIBED
K071175 · Ge Healthcare · Jul 2007