Cleared Traditional

K073087 - NON-CONTACT TONOMETER

K073087 is an FDA 510(k) clearance for NON-CONTACT TONOMETER, manufactured by Tomey Corporation. The device is a Class 2 Ophthalmic device with product code HKX cleared through the Traditional 510(k) pathway after a 383-day FDA review.

K073087 · Tomey Corporation · Ophthalmic device
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Nov 2008
Decision
383d
Days
Class 2
Risk

K073087 is an FDA 510(k) clearance for the NON-CONTACT TONOMETER, MODEL FT-1000. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Tomey Corporation (Tokyo, JP). The FDA issued a Cleared decision on November 18, 2008 after a review of 383 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Tomey Corporation devices

FDA 510(k) Submission Details - K073087

510(k) Number K073087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2007
Decision Date November 18, 2008
Days to Decision 383 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
273d slower than avg
Panel avg: 110d · This submission: 383d
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 23
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K073087.
Keeler TonoCare Tonometer
K181143 · Keeler Instruments, Inc. · Feb 2019
Tono Vue Non-Contact Tonometer
K180820 · Crystalvue Medical Corporation · Dec 2018
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
K093298 · Keeler Instruments, Inc. · Dec 2010
NON-CONTACT TONOMETER, MODEL NT-4000
K031733 · Nidek, Inc. · Dec 2003
MODEL 30 CLASSIC PNEUMATONOMETER
K002395 · Xomed, Inc. · Dec 2000
KEELER PULSAIR 3000 NON CONTACT TONOMETER
K990257 · Keeler Instruments, Inc. · Mar 1999