Cleared Traditional

K182199 - NFC-700 non-mydriatic auto fundus camera

K182199 is an FDA 510(k) clearance for NFC-700 non-mydriatic auto fundus camera, manufactured by Crystalvue Medical Corporation. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K182199 · Crystalvue Medical Corporation · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2019
Decision
141d
Days
Class 2
Risk

K182199 is an FDA 510(k) clearance for the NFC-700 non-mydriatic auto fundus camera. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Crystalvue Medical Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on January 2, 2019 after a review of 141 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 Crystalvue Medical Corporation devices

FDA 510(k) Submission Details - K182199

510(k) Number K182199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2018
Decision Date January 02, 2019
Days to Decision 141 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
31d slower than avg
Panel avg: 110d · This submission: 141d
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 59
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K182199.
KOWA nonmyd 8
K191945 · Kowa Company , Ltd. · Sep 2019
KOWA DR-1a
K190573 · Kowa Company , Ltd. · Jun 2019
Microperimeter MP-3, Microperimeter MP-3 Type S
K190198 · Nidek Co., Ltd. · Apr 2019
3nethra neo
K183059 · Forus Health Pvt.Ltd · Dec 2018
LipiScan Dynamic Meibomian Imager
K182506 · Tearscience, Inc. · Dec 2018
RetCam 3
K182263 · Natus Medical Incorporated · Sep 2018