Cleared Special

K171165 - SmartByte Device

K171165 is an FDA 510(k) clearance for SmartByte Device, manufactured by Scientific Intake. The device is a Class 2 Gastroenterology & Urology device with product code ONY cleared through the Special 510(k) pathway after a 28-day FDA review.

K171165 · Scientific Intake · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
28d
Days
Class 2
Risk

K171165 is an FDA 510(k) clearance for the SmartByte Device. Classified as Oral Removable Retainer For Weight Management (product code ONY), Class II - Special Controls.

Submitted by Scientific Intake (Lawrence, US). The FDA issued a Cleared decision on May 18, 2017 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5981 - the FDA gastroenterology and urology 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.

FDA 510(k) Submission Details - K171165

510(k) Number K171165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2017
Decision Date May 18, 2017
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 131d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

ONY Device Classification - Class 2, Special Controls

Product Code ONY Oral Removable Retainer For Weight Management
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5981
Definition A Removable Oral Device Used During Meals To Limit Food Intake.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice M. Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

K171165 · SmartByte Device
Download PDF FDA Summary Scientific Intake