510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171165Substantially Equivalent

SmartByte Device

Scientific Intake, Lawrence MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171165 is the FDA 510(k) clearance record for SmartByte Device, a class II device, cleared for Scientific Intake on under FDA product code ONY (Oral Removable Retainer For Weight Management). FDA's definition for product code ONY reads: "A removable oral device used during meals to limit food intake". FDA records list 2 510(k) clearances for Scientific Intake, from to . As of , FDA records show no recalls naming K171165.

Clearance record

Decision date
Received
(28 days to decision)
Product code
ONY Oral Removable Retainer For Weight Management
Regulation
21 CFR 876.5981
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Scientific Intake 280 Merrimack St. Suite 503, Lawrence MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONY

Trailing 12 months

FDA records hold no clearances under product code ONY in the trailing twelve months.

FDA records show no clearances under product code ONY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ONY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260