Cleared Traditional

K132917 - OCULAR FORCE GAUGE

K132917 is an FDA 510(k) clearance for OCULAR FORCE GAUGE, manufactured by Ocular Therapeutix, Inc.. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K132917 · Ocular Therapeutix, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
94d
Days
Class 2
Risk

K132917 is an FDA 510(k) clearance for the OCULAR FORCE GAUGE. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Ocular Therapeutix, Inc. (Bedford, US). The FDA issued a Cleared decision on December 20, 2013 after a review of 94 days - within the typical 510(k) review window.

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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K132917

510(k) Number K132917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2013
Decision Date December 20, 2013
Days to Decision 94 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
16d faster than avg
Panel avg: 110d · This submission: 94d
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 Peers - HKY Tonometer, Manual

All 49
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K132917.
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K133234 · Keeler Limited · Feb 2014
KEELER APPLANATION TONOMETER
K093445 · Keeler, Ltd. · Jan 2010
FALCK APPLANATION TONOMETER (FAT2)
K071755 · Falck Medical, Inc. · Jun 2008
ICARE TONOMETER TA01I
K063873 · Tiolat OY · May 2007