Cleared Traditional

K884989 - NEVISCAN MODEL N - 100

K884989 is an FDA 510(k) clearance for NEVISCAN MODEL N - 100, manufactured by Special Products, Inc.. The device is a Class 2 Hematology device with product code HKI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K884989 · Special Products, Inc. · Hematology device
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Feb 1989
Decision
89d
Days
Class 2
Risk

K884989 is an FDA 510(k) clearance for the NEVISCAN MODEL N - 100. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Special Products, Inc. (Milford, US). The FDA issued a Cleared decision on February 28, 1989 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 886.1120 - the FDA hematology 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 Special Products, Inc. devices

FDA 510(k) Submission Details - K884989

510(k) Number K884989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1988
Decision Date February 28, 1989
Days to Decision 89 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 113d · This submission: 89d
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 Hematology devices follow this clearance model.

Regulatory Peers - HKI Camera, Ophthalmic, Ac-powered

All 111
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K884989.
CANDELA RETINAL CAMERA
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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