Cleared Traditional

K811245 - OPHTHALMIC SCISSORS

K811245 is an FDA 510(k) clearance for OPHTHALMIC SCISSORS, manufactured by Keeler Instruments, Inc.. The device is a Class 1 Ophthalmic device with product code HNF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K811245 · Keeler Instruments, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1981
Decision
88d
Days
Class 1
Risk

K811245 is an FDA 510(k) clearance for the OPHTHALMIC SCISSORS. Classified as Scissors, Ophthalmic (product code HNF), Class I - General Controls.

Submitted by Keeler Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 31, 1981 after a review of 88 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 Keeler Instruments, Inc. devices

FDA 510(k) Submission Details - K811245

510(k) Number K811245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1981
Decision Date July 31, 1981
Days to Decision 88 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 110d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

HNF Device Classification - Class 1, General Controls

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 11
Devices cleared under the same product code (HNF) and FDA review panel - the closest regulatory comparables to K811245.
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
SCISSORS, STRABIMUS, 4 STRAIGHT
K770040 · J. Sklar Mfg. Co., Inc. · Jan 1977
SCISSORS, STRABISMUS, 4 CURVED
K770041 · J. Sklar Mfg. Co., Inc. · Jan 1977
SCISSORS, IRIS
K770019 · J. Sklar Mfg. Co., Inc. · Jan 1977