Cleared Traditional

K140450 - KEELER KAPTURE SOFTWARE

K140450 is an FDA 510(k) clearance for KEELER KAPTURE SOFTWARE, manufactured by Keeler Limited. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K140450 · Keeler Limited · Ophthalmic device
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Jun 2014
Decision
113d
Days
Class 2
Risk

K140450 is an FDA 510(k) clearance for the KEELER KAPTURE SOFTWARE. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Keeler Limited (Broomall, US). The FDA issued a Cleared decision on June 17, 2014 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - 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.

View all Keeler Limited devices

FDA 510(k) Submission Details - K140450

510(k) Number K140450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2014
Decision Date June 17, 2014
Days to Decision 113 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
3d slower than avg
Panel avg: 110d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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 - HKI Camera, Ophthalmic, Ac-powered

All 104
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K140450.
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COBRA FUNDUS CAMERA
K132987 · C.S.O. S.R.L. · Jul 2014
OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
K132186 · Optomed OY · Dec 2013
IFUSION
K130656 · Optovue, Inc. · Jul 2013
TRC-50DX RETINAL CAMERA
K123101 · Topcon Medical Systems, Inc. · Jun 2013