Cleared Traditional

K931675 - MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS

K931675 is an FDA 510(k) clearance for MEDLINE'S EXAMIN, manufactured by Medline Industries, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTD cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K931675 · Medline Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
322d
Days
Class 2
Risk

K931675 is an FDA 510(k) clearance for the MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS. Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K931675

510(k) Number K931675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1993
Decision Date February 22, 1994
Days to Decision 322 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 115d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTD Device Classification - Class 2, Special Controls

Product Code FTD Lamp, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTD Lamp, Surgical

All 28
Devices cleared under the same product code (FTD) and FDA review panel - the closest regulatory comparables to K931675.
STRYKER KNIFELIGHT
K961122 · Stryker Instruments · Aug 1996
XE-LITE
K954263 · Ophthalmic Technologies, Inc. · Oct 1995
GENESIS
K942553 · Burton Medical Products Corp. · Jun 1994
HANAULUX 2005 SURGICAL LIGHT
K932451 · Heraeus Instruments GmbH · Nov 1993
MI-15 EXAM SURGICAL LIGHT
K930897 · Medical Illumination, Inc. · Jun 1993
HANAULUX(R) 2000
K895715 · W.C. Heraeus GmbH · Oct 1989
K931675 · MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS
Download PDF FDA Summary Medline Industries, I…