Cleared Traditional

K152308 - Sensor Medical Single Use Tonometer Prism

K152308 is the FDA 510(k) clearance for Sensor Medical Single Use Tonometer Prism by Sensor Medical Technology, LLC. It is a Class 2 Ophthalmic device (product code HKY) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K152308 · Sensor Medical Technology, LLC · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
60d
Days
Class 2
Risk

K152308 is an FDA 510(k) clearance for the Sensor Medical Single Use Tonometer Prism. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Sensor Medical Technology, LLC (Maple Valley, US). The FDA issued a Cleared decision on October 13, 2015 after a review of 60 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 Sensor Medical Technology, LLC devices

Submission Details

510(k) Number K152308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2015
Decision Date October 13, 2015
Days to Decision 60 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
50d faster than avg
Panel avg: 110d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 17
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K152308.
Applanation tonometer AT-2
K182491 · Takagi Seiko Co., Ltd. · Dec 2018
AT 030
K180839 · Carl Zeiss Meditec, AG · Jun 2018
CATS Tonometer Prism
K173904 · Cats Tonometer, LLC · Mar 2018
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
K053430 · Medtronic Xomed, Inc. · Mar 2006
PROVIEW EYE PRESSURE MONITOR
K011199 · Bausch & Lomb, Inc. · Jul 2001
JAKOBI SURG. INSTRUMENTS #6 50
K834187 · Imm Enterprises , Ltd. · Mar 1984