Cleared Traditional

K992998 - AUTOMATED OPHTHALMICS SOFTIPS

K992998 is an FDA 510(k) clearance for AUTOMATED OPHTHALMICS SOFTIPS, manufactured by Automated Ophthalmics, Inc.. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K992998 · Automated Ophthalmics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
125d
Days
Class 2
Risk

K992998 is an FDA 510(k) clearance for the AUTOMATED OPHTHALMICS SOFTIPS. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Automated Ophthalmics, Inc. (Ellicott City, US). The FDA issued a Cleared decision on January 10, 2000 after a review of 125 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Automated Ophthalmics, Inc. devices

FDA 510(k) Submission Details - K992998

510(k) Number K992998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1999
Decision Date January 10, 2000
Days to Decision 125 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 110d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKY Device Classification - Class 2, Special Controls

Product Code HKY Tonometer, Manual
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 - HKY Tonometer, Manual

All 25
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K992998.
PROVIEW EYE PRESSURE MONITOR
K011199 · Bausch & Lomb, Inc. · Jul 2001
C.S.O. TONOMETER
K992835 · Cso · Jun 2000
FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER
K991840 · Bernard B. Fresco · Mar 2000
GOLDMAN MANUAL TONOMETER
K981432 · Golden Vision, Inc. · Jan 1999
BLOOD FLOW ANALYZER
K970887 · Paradigm Medical Industries, Inc. · Jun 1997
PERKINS HAND-HELD APPLANATION TONOMETER
K961512 · Clement Clarke, Inc. · Jul 1996