Cleared Traditional

K940996 - OLYMPIC BILI-LITE

K940996 is an FDA 510(k) clearance for OLYMPIC BILI-LITE, manufactured by Olympic Medical Corp.. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K940996 · Olympic Medical Corp. · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K940996

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
Combination Product No
PCCP Authorized No
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.

LBI Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K940996.
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
K991627 · Respironics, Inc. · May 1999
DUO-LITE PHOTOTHERAPY SYSTEM
K971256 · Air-Shields, Inc. · Sep 1997
OLYMPIC BILI-BASSINET
K971601 · Olympic Medical Corp. · Sep 1997
BILIBLANKET LIGHT METER
K910571 · Ohmeda Medical · Jul 1992
OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR
K903445 · Olympic Medical Corp. · Oct 1990
OLYMPIC MINI BILI-LITE, MODEL 77
K902749 · Olympic Medical Corp. · Aug 1990