Cleared Traditional

BILI-THERAPY SPOT TYPE (K103828) - FDA 510(k) Clearance

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

K103828 · Atom Medical Corporation · General Hospital
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Mar 2011
Decision
91d
Days
Class 2
Risk

K103828 is an FDA 510(k) clearance for the BILI-THERAPY SPOT TYPE. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Atom Medical Corporation (Bonita Springs, US). The FDA issued a Cleared decision on March 29, 2011 after a review of 91 days - within the typical 510(k) review window.

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.

View all Atom Medical Corporation devices

Submission Details

510(k) Number K103828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2010
Decision Date March 29, 2011
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 11
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K103828.
bili-hut
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BiliLux
K172656 · Draeger Medical Systems, Inc. · May 2018
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
K011549 · Ohmeda Medical · Jul 2001
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
K991627 · Respironics, Inc. · May 1999
BILIBLANKET LIGHT METER
K910571 · Ohmeda Medical · Jul 1992