Cleared Special

K182263 - RetCam 3

Also marketed or referenced as:
RetCam Shuttle RetCam Portable

K182263 is the FDA 510(k) clearance for RetCam 3 by Natus Medical Incorporated. It is a Class 2 Ophthalmic device (product code HKI) cleared through the Special 510(k) pathway after a 17-day FDA review.

K182263 · Natus Medical Incorporated · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
17d
Days
Class 2
Risk

K182263 is an FDA 510(k) clearance for the RetCam 3. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Natus Medical Incorporated (Pleasanton, US). The FDA issued a Cleared decision on September 7, 2018 after a review of 17 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Natus Medical Incorporated devices

Submission Details

510(k) Number K182263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2018
Decision Date September 07, 2018
Days to Decision 17 days
Submission Type Special
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
93d faster than avg
Panel avg: 110d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

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

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