Cleared Traditional

K882071 - CRANK FRAME RETRACTOR

K882071 is an FDA 510(k) clearance for CRANK FRAME RETRACTOR, manufactured by Karlin Technology, Inc.. The device is a Class 2 Neurology device with product code GZT cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K882071 · Karlin Technology, Inc. · Neurology device
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Jun 1988
Decision
24d
Days
Class 2
Risk

K882071 is an FDA 510(k) clearance for the CRANK FRAME RETRACTOR. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Karlin Technology, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on June 10, 1988 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4800 - the FDA neurology 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 - K882071

510(k) Number K882071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1988
Decision Date June 10, 1988
Days to Decision 24 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 148d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZT Device Classification - Class 2, Special Controls

Product Code GZT Retractor, Self-retaining, For Neurosurgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4800
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 Neurology devices follow this clearance model.

Regulatory Peers - GZT Retractor, Self-retaining, For Neurosurgery

All 19
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K882071.
CODMAN LHALO SPLIT RING RETRACTOR SYSTEM
K913233 · Codman & Shurtleff, Inc. · Jul 1991
V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR
K895395 · Baxter Healthcare Corp · Oct 1989
NEUROSURICAL RETRACTORS - VARIOUS TYPES
K892543 · Zinnanti Surgical Instruments, Inc. · May 1989
CRANK FRAME RETRACTOR
K881160 · T. Korossurgical Instruments Corp. · Apr 1988
CEDAR(TM) RETRACTOR RING
K873691 · Cedar Surgical, Inc. · Sep 1987
BUDDE-HALO RETRACTOR
K830332 · Ohio Medical Instrument Co., Inc. · Mar 1983