Cleared Traditional

K001275 - RETCAM II

K001275 is an FDA 510(k) clearance for RETCAM II, manufactured by Massie Research Laboratories, Inc.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K001275 · Massie Research Laboratories, Inc. · Ophthalmic device
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Jul 2000
Decision
84d
Days
Class 2
Risk

K001275 is an FDA 510(k) clearance for the RETCAM II. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Massie Research Laboratories, Inc. (Dublin, US). The FDA issued a Cleared decision on July 13, 2000 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K001275

510(k) Number K001275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2000
Decision Date July 13, 2000
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 110d · This submission: 84d
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 153
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K001275.
ISCREEN VISION SCREENER
K010315 · Iscreen, LLC · Jun 2001
MEGAVISION CPX, MEGAVISION FA, MODEL I AND II
K002920 · Escalon Medical Corp. · Dec 2000
RETINADX
K003236 · Regulatory Associates, Inc. · Nov 2000
EYECAP IMAGING SYSTEM
K000368 · Clement Clarke Intl., Ltd. · May 2000
DIGISCOPE OPHTHALMIC CAMERA
K990205 · Eye Tel Imaging, Inc. · Mar 1999
WINSTATION RETINAL IMAGER
K982689 · Ophthalmic Imaging Systems · Oct 1998
K001275 · RETCAM II
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