Cleared Traditional

K843354 - EPISCLERAL VENOUS PRESSURE

K843354 is the FDA 510(k) clearance for EPISCLERAL VENOUS PRESSURE by Eyetech, LLC. It is a Class 2 Ophthalmic device (product code HKX) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K843354 · Eyetech, LLC · Ophthalmic device
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Nov 1984
Decision
84d
Days
Class 2
Risk

K843354 is an FDA 510(k) clearance for the EPISCLERAL VENOUS PRESSURE. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Eyetech, LLC (Chicago, US). The FDA issued a Cleared decision on November 19, 1984 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - 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 Eyetech, LLC devices

Submission Details

510(k) Number K843354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1984
Decision Date November 19, 1984
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 110d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKX Tonometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HKX Tonometer, Ac-powered

All 23
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K843354.
KEELER PULSAIR NON CONTACT TONOMETER
K870750 · Keeler Instruments, Inc. · Mar 1987
DIGILAB MICRO ONE APPLANATION TONOMETER
K870121 · Bio-Rad · Feb 1987
DIGILAB MODULAR ONE-APPLANATION TONOMETER
K863217 · Bio-Rad · Sep 1986
CAT 100
K840836 · CooperVision, Inc. · Jun 1984
CLERZ LUBRICATING/REWETTING SOLUTION
K833494 · CooperVision, Inc. · Jan 1984
AO NON-CONTACT II TONOMETER
K802419 · American Optical Corp. · Nov 1980