Cleared Traditional

K890992 - WOODLYN OPHTHALMIC PROJECTOR

K890992 is an FDA 510(k) clearance for WOODLYN OPHTHALMIC PROJECTOR, manufactured by Woodlyn, Inc.. The device is a Class 1 Ophthalmic device with product code HOS cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K890992 · Woodlyn, Inc. · Ophthalmic device
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May 1989
Decision
79d
Days
Class 1
Risk

K890992 is an FDA 510(k) clearance for the WOODLYN OPHTHALMIC PROJECTOR. Classified as Projector, Ophthalmic (product code HOS), Class I - General Controls.

Submitted by Woodlyn, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on May 17, 1989 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1680 - 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 Woodlyn, Inc. devices

FDA 510(k) Submission Details - K890992

510(k) Number K890992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1989
Decision Date May 17, 1989
Days to Decision 79 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
31d faster than avg
Panel avg: 110d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

HOS Device Classification - Class 1, General Controls

Product Code HOS Projector, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1680
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 - HOS Projector, Ophthalmic

Devices cleared under the same product code (HOS) and FDA review panel - the closest regulatory comparables to K890992.
WIRELESS CHART PROJECTOR,HCP-W 721
K936200 · Canon USA, Inc. · Sep 1994
BURTON PROJECTOR HEAD - MODEL 6000-H
K924784 · R.H. Burton Co. · Apr 1993
BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR
K862519 · Bausch & Lomb, Inc. · Jul 1986
ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ
K811180 · American Optical Corp. · May 1981
PROJECTOR, ACCU-CHART ACUITY
K781658 · Bausch & Lomb, Inc. · Oct 1978