Cleared Traditional

K140450 - KEELER KAPTURE SOFTWARE

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

K140450 · Keeler Limited · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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 59
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K140450.
RetiCapture
K173474 · Ilooda Co,., Ltd. · Jul 2018
Nexy
K180306 · Next Sight Srl · Jun 2018
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
K180378 · Optomed OY · Apr 2018
PANOPTIC
K121405 · Welch Allyn, Inc. · Dec 2012
DIGITAL RETINAL CAMERA
K111612 · Canon, Inc. · Sep 2011
DIGITAL RETINAL CAMERA, CR-1 MARK II
K090466 · Canon, Inc. · Mar 2009