Cleared Traditional

K851112 - RANDALL KIDNEY STONE FORCEPS 817-144 PC...

K851112 is an FDA 510(k) clearance for RANDALL KIDNEY STONE FORCEPS 817-144 PC..., manufactured by The Huxley Instrument Corp.. The device is a Class 1 Gastroenterology & Urology device with product code KOA cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K851112 · The Huxley Instrument Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
15d
Days
Class 1
Risk

K851112 is an FDA 510(k) clearance for the RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on April 3, 1985 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - the FDA gastroenterology and urology 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 The Huxley Instrument Corp. devices

FDA 510(k) Submission Details - K851112

510(k) Number K851112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1985
Decision Date April 03, 1985
Days to Decision 15 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

KOA Device Classification - Class 1, General Controls

Product Code KOA Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
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 - KOA Surgical Instruments, G-u, Manual (and Accessories)

All 24
Devices cleared under the same product code (KOA) and FDA review panel - the closest regulatory comparables to K851112.
ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420
K852726 · The Huxley Instrument Corp. · Jul 1985
AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER
K851162 · Van-Tec, Inc. · Apr 1985
RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV
K851111 · The Huxley Instrument Corp. · Apr 1985
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR
K851113 · The Huxley Instrument Corp. · Apr 1985
WESTON RECTAL SNARE
K841387 · Imm Enterprises , Ltd. · May 1984
OP-CON SURG. INSTRUMENT #3
K834171 · Imm Enterprises , Ltd. · Apr 1984