Cleared Traditional

K852727 - ROCHESTER - PEAN FORCEPS

K852727 is an FDA 510(k) clearance for ROCHESTER - PEAN FORCEPS, manufactured by The Huxley Instrument Corp.. The device is a Class 1 General & Plastic Surgery device with product code HTD cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K852727 · The Huxley Instrument Corp. · General & Plastic Surgery device
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Jul 1985
Decision
19d
Days
Class 1
Risk

K852727 is an FDA 510(k) clearance for the ROCHESTER - PEAN FORCEPS, STRAIGHT, 6-1/4+SS. Classified as Forceps (product code HTD), Class I - General Controls.

Submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on July 15, 1985 after a review of 19 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 The Huxley Instrument Corp. devices

FDA 510(k) Submission Details - K852727

510(k) Number K852727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1985
Decision Date July 15, 1985
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

HTD Device Classification - Class 1, General Controls

Product Code HTD Forceps
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 - HTD Forceps

All 54
Devices cleared under the same product code (HTD) and FDA review panel - the closest regulatory comparables to K852727.
THUMB DRESSING FORCEPS, 5+SS 410 OR 420
K852720 · The Huxley Instrument Corp. · Jul 1985
STERILIZING FORCEPS, 3-PRONGE, 11+SS 410 OR 420
K852722 · The Huxley Instrument Corp. · Jul 1985
FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420
K852723 · The Huxley Instrument Corp. · Jul 1985
KELLY HEMOSTATIC FORCEPS, STRAIGHT 5-1/2+SS
K852728 · The Huxley Instrument Corp. · Jul 1985
AALSTEAD MOSQ. FORCEPS, STRAIGHT, 5+SS 410 OR 420
K852729 · The Huxley Instrument Corp. · Jul 1985
VARIOUS DRESSING/TISSUE FORCEPS(ENGLISH, THUMB, TR
K851769 · Artiberia · Jun 1985