Cleared Traditional

K822151 - SURGICAL INSTRUMENTS REPRESENT. 4 CLASS

K822151 is the FDA 510(k) clearance for SURGICAL INSTRUMENTS REPRESENT. 4 CLASS by Robert I. Chien & Assoc., Inc.. It is a Class 1 Ophthalmic device (product code HNF) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K822151 · Robert I. Chien & Assoc., Inc. · Ophthalmic device
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Aug 1982
Decision
28d
Days
Class 1
Risk

K822151 is an FDA 510(k) clearance for the SURGICAL INSTRUMENTS REPRESENT. 4 CLASS. Classified as Scissors, Ophthalmic (product code HNF), Class I - General Controls.

Submitted by Robert I. Chien & Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 19, 1982 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - the FDA ophthalmic 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 Robert I. Chien & Assoc., Inc. devices

Submission Details

510(k) Number K822151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1982
Decision Date August 19, 1982
Days to Decision 28 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 110d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNF Scissors, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
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 - HNF Scissors, Ophthalmic

All 9
Devices cleared under the same product code (HNF) and FDA review panel - the closest regulatory comparables to K822151.
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
K873099 · Alcon Laboratories · Sep 1987
13-550,13-560 WESCOTT SCOSSORS (EYE)
K851768 · Artiberia · Jun 1985
IRIS SCISSORS STRAIGHT 4 1/2
K821286 · Conphar, Inc. · May 1982
LITTAUER SCISSORS 5 1/2
K821290 · Conphar, Inc. · May 1982
OPHTHALMIC SCISSORS
K811245 · Keeler Instruments, Inc. · Jul 1981
SCISSORS, MICRO IRIS STRAIGHT
K760185 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1976