Cleared Traditional

ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR (K853114) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K853114 · Australian Biomedical Corporation , Ltd. · General & Plastic Surgery device
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Aug 1985
Decision
13d
Days
Class 1
Risk

K853114 is an FDA 510(k) clearance for the ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Australian Biomedical Corporation , Ltd. (Australia, AU). The FDA issued a Cleared decision on August 6, 1985 after a review of 13 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 Australian Biomedical Corporation , Ltd. devices

Submission Details

510(k) Number K853114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1985
Decision Date August 06, 1985
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 99
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K853114.
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
K132645 · Medtronic, Inc. · Oct 2013
AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
K914190 · United States Surgical, A Division of Tyco Healthc · May 1992
STERI-TRACTOR WOUND RETRACTOR
K870543 · 3M Company · Feb 1987
3M FUKUDA TYPE RING RETRACTOR
K852567 · 3M Company · Jul 1985
FLEXI-TY
K832765 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1984
ZIMMER SKIN PROTECTOR
K830287 · Zimmer, Inc. · Mar 1983