Cleared Traditional

OLYMPIC BILI-LITE (K940996) - FDA 510(k) Clearance

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

K940996 · Olympic Medical Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Sep 1994
Decision
196d
Days
Class 2
Risk

K940996 is an FDA 510(k) clearance for the OLYMPIC BILI-LITE. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on September 16, 1994 after a review of 196 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.

View all Olympic Medical Corp. devices

Submission Details

510(k) Number K940996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1994
Decision Date September 16, 1994
Days to Decision 196 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
67d slower than avg
Panel avg: 129d · This submission: 196d
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 K940996.
BiliLux
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K991627 · Respironics, Inc. · May 1999
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K910571 · Ohmeda Medical · Jul 1992
BILIBLANKET PHOTOTHERAPY DEVICE
K894129 · Ohmeda Medical · Sep 1989