Cleared Traditional

K142332 - BT-400 (FDA 510(k) Clearance)

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

K142332 · Bio-Med USA · General Hospital
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Mar 2015
Decision
212d
Days
Class 2
Risk

K142332 is an FDA 510(k) clearance for the BT-400. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Bio-Med USA (Ramsey, US). The FDA issued a Cleared decision on March 20, 2015 after a review of 212 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5700 - 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.

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Submission Details

510(k) Number K142332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2014
Decision Date March 20, 2015
Days to Decision 212 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
84d slower than avg
Panel avg: 128d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBI Unit, Neonatal Phototherapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5700
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 - LBI Unit, Neonatal Phototherapy

All 70
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K142332.
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
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K210289 · Bistos Co., Ltd. · May 2021
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bili-hut
K190899 · Little Sparrows Technologies, Inc. · Sep 2019