Cleared Traditional

K992835 - C.S.O. TONOMETER

K992835 is an FDA 510(k) clearance for C.S.O. TONOMETER, manufactured by Cso. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K992835 · Cso · Ophthalmic device
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Jun 2000
Decision
288d
Days
Class 2
Risk

K992835 is an FDA 510(k) clearance for the C.S.O. TONOMETER. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Cso (Williamsville, US). The FDA issued a Cleared decision on June 6, 2000 after a review of 288 days - an extended review 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: 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.

FDA 510(k) Submission Details - K992835

510(k) Number K992835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1999
Decision Date June 06, 2000
Days to Decision 288 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
178d slower than avg
Panel avg: 110d · This submission: 288d
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 51
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K992835.
LUNEAU STERILE TONOMETER SEPARATION PRISMS
K023838 · Luneau SA · Feb 2003
F 900
K022054 · C.S.O. S.R.L. · Aug 2002
PROVIEW EYE PRESSURE MONITOR
K011199 · Bausch & Lomb, Inc. · Jul 2001
REICHERT CT200 CONTACT TONOMETER
K000288 · Reichert Ophthalmic Instruments, Div. Leica, Inc. · Mar 2000
FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER
K991840 · Bernard B. Fresco · Mar 2000
AUTOMATED OPHTHALMICS SOFTIPS
K992998 · Automated Ophthalmics, Inc. · Jan 2000
K992835 · C.S.O. TONOMETER
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