Cleared Traditional

K842045 - WOODLYN CLASSIC EXAM. CHAIR

K842045 is an FDA 510(k) clearance for WOODLYN CLASSIC EXAM. CHAIR, manufactured by Woodlyn, Inc.. The device is a Class 1 Ophthalmic device with product code HME cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K842045 · Woodlyn, Inc. · Ophthalmic device

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Jun 1984

Decision

29d

Days

Class 1

Risk

K842045 is an FDA 510(k) clearance for the WOODLYN CLASSIC EXAM. CHAIR. Classified as Chair, Ophthalmic, Ac-powered (product code HME), Class I - General Controls.

Submitted by Woodlyn, Inc. (Walker, US). The FDA issued a Cleared decision on June 19, 1984 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1140 - 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.

FDA 510(k) Submission Details - K842045

510(k) Number	K842045 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 21, 1984
Decision Date	June 19, 1984
Days to Decision	29 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

81d faster than avg

Panel avg: 110d · This submission: 29d

Pathway characteristics

Predicate-based equivalence.

HME Device Classification - Class 1, General Controls

Product Code	HME Chair, Ophthalmic, Ac-powered
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 886.1140

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 - HME Chair, Ophthalmic, Ac-powered

All 15

Devices cleared under the same product code (HME) and FDA review panel - the closest regulatory comparables to K842045.

RELIANCE 1000, RELIANCE 1500, RELIANCE 2000

K853149 · F. & F. Koenigkramer · Sep 1985

RELIANCE 6100

K853150 · F. & F. Koenigkramer · Sep 1985

RELIANCE 5000

K853151 · F. & F. Koenigkramer · Sep 1985

DOWING OPHTHALMIC CHAIR AC-POWERED

K833539 · Vision Health Technology · Mar 1984

A O CUSTOM II CHAIR AND STAND

K801638 · American Optical Corp. · Aug 1980

MAXI-CHAIR

K781801 · Surgical Mechanical Research, Inc. · Nov 1978

FDA 510(k) Resources - Ophthalmic

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K842045

Woodlyn, Inc.

Walker, MI · US

Regulatory profile

19 submissions 19 cleared

100% clearance rate · Active in Ophthalmic

View all devices by Woodlyn, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: June 19, 1984. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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