Cleared Traditional

K152308 - Sensor Medical Single Use Tonometer Prism

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

K152308 · Sensor Medical Technology, LLC · Ophthalmic device
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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

FDA 510(k) Submission Details - K152308

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
Combination Product No
PCCP Authorized No
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.

HKY Device Classification - Class 2, Special Controls

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 Consultant

O'Connell Regulatory Consultants, Inc.
Maureen O'Connell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HKY Tonometer, Manual

All 37
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K152308.
Applanation Tonometer
K142263 · Shanghai Mediworks Precision Instruments Co. , Ltd. · Apr 2016
Falck Medical Multifunction Tonometer, FAT1
K151491 · Falck Medical, Inc. · Jan 2016
KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100
K152644 · Keeler Limited · Dec 2015
D-KAT Z-YPE
K142179 · Keeler, Ltd. · Sep 2014
ACCUTIP COVER
K132549 · Accutome, Inc. · Apr 2014
T-TYPE D-KAT, R-TYPE D-KAT
K133234 · Keeler Limited · Feb 2014