Cleared Traditional

K132543 - INFANT INCUBATOR

K132543 is an FDA 510(k) clearance for INFANT INCUBATOR, manufactured by Bistos Co., Ltd.. The device is a Class 2 General Hospital device with product code FMZ cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K132543 · Bistos Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K132543

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
Combination Product No
PCCP Authorized No
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.

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 Peers - FMZ Incubator, Neonatal

All 63
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