Cleared Traditional

NIDEK MODEL NT-1000 (K913189) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K913189 · Nidek, Inc. · Ophthalmic device
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Oct 1991
Decision
89d
Days
Class 2
Risk

K913189 is an FDA 510(k) clearance for the NIDEK MODEL NT-1000. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Nidek, Inc. (Palo Alto, US). The FDA issued a Cleared decision on October 15, 1991 after a review of 89 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 Nidek, Inc. devices

Submission Details

510(k) Number K913189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1991
Decision Date October 15, 1991
Days to Decision 89 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
21d faster than avg
Panel avg: 110d · This submission: 89d
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 11
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K913189.
Tono Vue Non-Contact Tonometer
K180820 · Crystalvue Medical Corporation · Dec 2018
TIP & MEMBRANE ASSEMBLY
K921443 · Bio-Rad · Jun 1993
CYLINDER OF GAS, CAN OF GAS (CC12F2)
K921617 · Bio-Rad · Aug 1992
BIO-RAD MODULAR AIR COMPRESSOR
K895575 · Bio-Rad · Oct 1989
DIGILAB MICRO ONE APPLANATION TONOMETER
K870121 · Bio-Rad · Feb 1987
DIGILAB MODULAR ONE-APPLANATION TONOMETER
K863217 · Bio-Rad · Sep 1986