Cleared Traditional

K931965 - MEDIX PHOTOTHERAPY LAMP

K931965 is an FDA 510(k) clearance for MEDIX PHOTOTHERAPY LAMP, manufactured by Medix I.C.S.A.. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K931965 · Medix I.C.S.A. · General Hospital
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Dec 1993
Decision
231d
Days
Class 2
Risk

K931965 is an FDA 510(k) clearance for the MEDIX PHOTOTHERAPY LAMP. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Medix I.C.S.A. (San Martin, Buenos Aires, AR). The FDA issued a Cleared decision on December 9, 1993 after a review of 231 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 Medix I.C.S.A. devices

FDA 510(k) Submission Details - K931965

510(k) Number K931965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1993
Decision Date December 09, 1993
Days to Decision 231 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 129d · This submission: 231d
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 41
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K931965.
BILIBED PHOTOTHERAPY LAMP
K962612 · Medela, Inc. · Dec 1996
DRAGER PT4000 PHOTOTHERAPY SYSTEM
K954611 · Drager, Inc. · Dec 1995
OLYMPIC BILI-LITE
K940996 · Olympic Medical Corp. · Sep 1994
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