Cleared Traditional

K990869 - LEICA AT550

K990869 is an FDA 510(k) clearance for LEICA AT550, manufactured by Leica Microsystems, Inc.. The device is a Class 2 Ophthalmic device with product code HKX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K990869 · Leica Microsystems, Inc. · Ophthalmic device
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Jun 1999
Decision
83d
Days
Class 2
Risk

K990869 is an FDA 510(k) clearance for the LEICA AT550. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Leica Microsystems, Inc. (Depew, US). The FDA issued a Cleared decision on June 7, 1999 after a review of 83 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 Leica Microsystems, Inc. devices

FDA 510(k) Submission Details - K990869

510(k) Number K990869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1999
Decision Date June 07, 1999
Days to Decision 83 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
27d faster than avg
Panel avg: 110d · This submission: 83d
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 28
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K990869.
KOWA KT-800
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K002395 · Xomed, Inc. · Dec 2000
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