Cleared Traditional

K011877 - FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM

K011877 is an FDA 510(k) clearance for FF450 PLUS FUNDUS CAMERA AND VISUPAC DI..., manufactured by Carl Zeiss Jena GmbH. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K011877 · Carl Zeiss Jena GmbH · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
103d
Days
Class 2
Risk

K011877 is an FDA 510(k) clearance for the FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450.... Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Carl Zeiss Jena GmbH (Washington, US). The FDA issued a Cleared decision on September 26, 2001 after a review of 103 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.

FDA 510(k) Submission Details - K011877

510(k) Number K011877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2001
Decision Date September 26, 2001
Days to Decision 103 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
7d faster than avg
Panel avg: 110d · This submission: 103d
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 156
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K011877.
FUNDUS AUTOIMAGER
K020888 · Visual Pathways, Inc. · Nov 2002
ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM
K022164 · Zeta Development Laboratories · Jul 2002
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
K014274 · Nidek, Inc. · Apr 2002
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
K011877 · FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM
Download PDF FDA Summary Carl Zeiss Jena GmbH