Cleared Traditional

K882075 - SELF-RETAINING SOFT TISSUE RETRACTOR

K882075 is an FDA 510(k) clearance for SELF-RETAINING SOFT TISSUE RETRACTOR, manufactured by Karlin Technology, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K882075 · Karlin Technology, Inc. · General & Plastic Surgery device
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Jun 1988
Decision
30d
Days
Class 1
Risk

K882075 is an FDA 510(k) clearance for the SELF-RETAINING SOFT TISSUE RETRACTOR. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Karlin Technology, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on June 16, 1988 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Karlin Technology, Inc. devices

FDA 510(k) Submission Details - K882075

510(k) Number K882075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1988
Decision Date June 16, 1988
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

GAD Device Classification - Class 1, General Controls

Product Code GAD Retractor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GAD Retractor

All 56
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K882075.
SURGICAL WIRE CUTTERS
K890250 · Kinetic Medical Products · Jan 1989
SUREBREATH DOME
K884076 · Ipax, Inc. · Oct 1988
SUCTION RETRACTORS
K882074 · Karlin Technology, Inc. · Jun 1988
STERNUM SPREADER AND MITRAL VALVE RETRACTOR
K881157 · T. Korossurgical Instruments Corp. · Apr 1988
UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR
K881156 · T. Korossurgical Instruments Corp. · Apr 1988
I.M.A. RETRACTOR
K881159 · T. Korossurgical Instruments Corp. · Apr 1988