Cleared Traditional

K871611 - ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540

K871611 is an FDA 510(k) clearance for ALLERGAN HUMPHREY AUTO-REFRACTOR, manufactured by Allergan Humphrey. The device is a Class 1 Ophthalmic device with product code HKO cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K871611 · Allergan Humphrey · Ophthalmic device
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May 1987
Decision
38d
Days
Class 1
Risk

K871611 is an FDA 510(k) clearance for the ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Allergan Humphrey (San Leandro, US). The FDA issued a Cleared decision on May 18, 1987 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1760 - 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 Allergan Humphrey devices

FDA 510(k) Submission Details - K871611

510(k) Number K871611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1987
Decision Date May 18, 1987
Days to Decision 38 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 110d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

HKO Device Classification - Class 1, General Controls

Product Code HKO Refractometer, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1760
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 - HKO Refractometer, Ophthalmic

All 21
Devices cleared under the same product code (HKO) and FDA review panel - the closest regulatory comparables to K871611.
CANON AUTOREFRACTOMETER R-22
K883200 · Canon USA, Inc. · Aug 1988
NIDEK ARK-2000
K882191 · Nidek, Inc. · Jul 1988
CANON AUTOREFRACTOMETER R-20
K882287 · Canon USA, Inc. · Jul 1988
BAUSCH & LOMB GR-3 REFRACTOR
K862521 · Bausch & Lomb, Inc. · Jul 1986
AR-1100 AUTOMATIC REFRACTOR
K861065 · Nidek, Inc. · Apr 1986
AR-1600 AUTOMATIC REFRACTOR
K861062 · Nidek, Inc. · Apr 1986