Cleared Traditional

K854330 - IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM

K854330 is the FDA 510(k) clearance for IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM by Par Technology Park. It is a Class 2 Ophthalmic device (product code HKI) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K854330 · Par Technology Park · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
46d
Days
Class 2
Risk

K854330 is an FDA 510(k) clearance for the IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Par Technology Park (New Hartford, US). The FDA issued a Cleared decision on December 13, 1985 after a review of 46 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.

View all Par Technology Park devices

Submission Details

510(k) Number K854330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date December 13, 1985
Days to Decision 46 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 110d · This submission: 46d
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 K854330.
MODIFIED RETINAL CAMERA MODEL CR4-45NM
K874017 · Canon USA, Inc. · Nov 1987
CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
K862323 · Canon USA, Inc. · Aug 1986
CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM
K855170 · Canon USA, Inc. · Feb 1986
GRC-WT, GRC-W
K843899 · Olympus Corp. · Jan 1985
CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM
K844898 · Canon USA, Inc. · Jan 1985
CANON 60 FUNDUS CAMERA CF-60U
K843021 · Canon USA, Inc. · Oct 1984