Cleared Traditional

K891758 - KINETIC MODEL 132

K891758 is an FDA 510(k) clearance for KINETIC MODEL 132, manufactured by Kinetic Biomedical Services, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FSS cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K891758 · Kinetic Biomedical Services, Inc. · General & Plastic Surgery device
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Apr 1989
Decision
27d
Days
Class 2
Risk

K891758 is an FDA 510(k) clearance for the KINETIC MODEL 132. Classified as Light, Surgical, Floor Standing (product code FSS), Class II - Special Controls.

Submitted by Kinetic Biomedical Services, Inc. (Erie, US). The FDA issued a Cleared decision on April 19, 1989 after a review of 27 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.

View all Kinetic Biomedical Services, Inc. devices

FDA 510(k) Submission Details - K891758

510(k) Number K891758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1989
Decision Date April 19, 1989
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSS Device Classification - Class 2, Special Controls

Product Code FSS Light, Surgical, Floor Standing
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 - FSS Light, Surgical, Floor Standing

All 12
Devices cleared under the same product code (FSS) and FDA review panel - the closest regulatory comparables to K891758.
HANAULUX BLUE 80 HOSPITAL
K970886 · Heraeus Med GmbH · Apr 1997
Q-5000
K961971 · Stryker Endoscopy · Jun 1996
LIGHTSOURCE OR ILLUMINATOR
K961074 · Cuda Products Co. · Apr 1996
LIGHT, SURGICAL, FLOOR STANDING
K880540 · Ferguson Medical · Feb 1988
GEMINI SURGICAL LIGHT
K880198 · American Sterilizer Co. · Feb 1988