Cleared Traditional

K941865 - XPERT NCT

K941865 is an FDA 510(k) clearance for XPERT NCT, manufactured by Reichert Ophthalmic Instruments, Div. Leica, Inc.. The device is a Class 2 Ophthalmic device with product code HKX cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K941865 · Reichert Ophthalmic Instruments, Div. Leica, Inc. · Ophthalmic device
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Sep 1994
Decision
164d
Days
Class 2
Risk

K941865 is an FDA 510(k) clearance for the XPERT NCT. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Reichert Ophthalmic Instruments, Div. Leica, Inc. (Depew, US). The FDA issued a Cleared decision on September 29, 1994 after a review of 164 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.

View all Reichert Ophthalmic Instruments, Div. Leica, Inc. devices

FDA 510(k) Submission Details - K941865

510(k) Number K941865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1994
Decision Date September 29, 1994
Days to Decision 164 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 110d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKX Device Classification - Class 2, Special Controls

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 34
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K941865.
KEELER PULSAIR 3000 NON CONTACT TONOMETER
K990257 · Keeler Instruments, Inc. · Mar 1999
CANON TX-10 TONOMETER
K963079 · Canon USA, Inc. · Mar 1997
NON-CONTACT TONOMETER T-2
K943939 · Canon, Inc. · May 1995
TIP & MEMBRANE ASSEMBLY
K921443 · Bio-Rad · Jun 1993
BURTON APPLANATION TONOMETER - MODEL T850 & T1000
K924777 · R.H. Burton Co. · Apr 1993
CYLINDER OF GAS, CAN OF GAS (CC12F2)
K921617 · Bio-Rad · Aug 1992