Cleared Traditional

K801353 - PARKE-DAVIS SURGICAL LIGHT

K801353 is an FDA 510(k) clearance for PARKE-DAVIS SURGICAL LIGHT, manufactured by Warner-Lambert Co.. The device is a Class 2 General & Plastic Surgery device with product code FTD cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K801353 · Warner-Lambert Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1980
Decision
21d
Days
Class 2
Risk

K801353 is an FDA 510(k) clearance for the PARKE-DAVIS SURGICAL LIGHT. Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by Warner-Lambert Co. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1980 after a review of 21 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K801353

510(k) Number K801353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1980
Decision Date June 30, 1980
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
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 K801353.
MINOR SURGICAL LIGHT MODEL 180
K841360 · American Sterilizer Co. · Apr 1984
SURGICAL LIGHT
K823360 · Amsco Co. · Dec 1982
CASTLE & RITTER MINOR SURG. & EXAM LT
K811728 · Sybron Corp. · Jul 1981
SURGICAL COLDLIGHT, AX8
K770861 · Affiliated Hospital Products, Inc. · Jun 1977
LIGHT, EXAMINATION, MEDICAL (MEL)
K770567 · Fiber Optics Engineering, Inc. · Apr 1977
SURGICAL ILLUMINATOR (SIL)
K770568 · Fiber Optics Engineering, Inc. · Apr 1977
K801353 · PARKE-DAVIS SURGICAL LIGHT
Download PDF Warner-Lambert Co.