Cleared Traditional

K003423 - ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055

K003423 is an FDA 510(k) clearance for ST. FRANCIS OPERATING THEATRE LAMP, manufactured by St. Francis Medical Equipment Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code FTD cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K003423 · St. Francis Medical Equipment Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
111d
Days
Class 2
Risk

K003423 is an FDA 510(k) clearance for the ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055. Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by St. Francis Medical Equipment Co., Ltd. (Taipei Shien, Taiwan, R.O.C., TW). The FDA issued a Cleared decision on February 22, 2001 after a review of 111 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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.

View all St. Francis Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K003423

510(k) Number K003423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2000
Decision Date February 22, 2001
Days to Decision 111 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 115d · This submission: 111d
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 14
Devices cleared under the same product code (FTD) and FDA review panel - the closest regulatory comparables to K003423.
STRYKER KNIFELIGHT
K100884 · Howmedica Osteonics Corp. · Jun 2010
ATRICURE DISSECTOR
K041681 · AtriCure, Inc. · Jul 2004
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
K013242 · STERIS Corporation · Dec 2001
STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR
K981717 · Stryker Instruments · Jun 1998
STRYKER KNIFELIGHT
K961122 · Stryker Instruments · Aug 1996
MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS
K931675 · Medline Industries, Inc. · Feb 1994