Cleared Traditional

K832686 - MULTIPLE MANUAL SURGICAL INSTRUMENTS

K832686 is an FDA 510(k) clearance for MULTIPLE MANUAL SURGICAL INSTRUMENTS, manufactured by Hirata Sangyo Co. USA, Inc.. The device is a Class 1 Orthopedic device with product code HTO cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K832686 · Hirata Sangyo Co. USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1983
Decision
73d
Days
Class 1
Risk

K832686 is an FDA 510(k) clearance for the MULTIPLE MANUAL SURGICAL INSTRUMENTS. Classified as Reamer (product code HTO), Class I - General Controls.

Submitted by Hirata Sangyo Co. USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory 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 Hirata Sangyo Co. USA, Inc. devices

FDA 510(k) Submission Details - K832686

510(k) Number K832686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1983
Decision Date October 14, 1983
Days to Decision 73 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 122d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

HTO Device Classification - Class 1, General Controls

Product Code HTO Reamer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
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 - HTO Reamer

All 12
Devices cleared under the same product code (HTO) and FDA review panel - the closest regulatory comparables to K832686.
COMBINATION REAMER
K903248 · Onyx Medical Corp. · Jul 1990
WARSAW ORTHOPEDIC POINTED REAMER
K870845 · Warsaw Orthopedic, Inc. · Mar 1987
ABC-1000 SMALL JOINT REAMERS
K862933 · Instrumentation Industries, Inc. · Aug 1986
MEDULLARY CANAL SCRAPERS
K811081 · The Anspach Effort, Inc. · Apr 1981
C.C.F. FEMORAL DEBRIDEMENT PROBE
K790996 · Depuy, Inc. · Jun 1979
FLEXIBLE REAMER, GUIDE WIRE SYSTEM
K790307 · 3M Company · Feb 1979