510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K163476Substantially Equivalent

Lubricity

You First Services, Incorporated, Amherst NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163476 is the FDA 510(k) clearance record for Lubricity, cleared for You First Services, Incorporated on under FDA product code LFD (Saliva, Artificial). FDA records list one 510(k) clearance for You First Services, Incorporated. As of , FDA records show no recalls naming K163476.

Clearance record

Decision date
Received
(149 days to decision)
Product code
LFD Saliva, Artificial
Device class
Unclassified
Review panel
Unknown
Applicant
You First Services, Incorporated 1576 Sweet Home Rd., Amherst NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFD

Trailing 12 months
1 clearance under product code LFD in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260