510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K193288Substantially Equivalent

Koya Ripple

Koya, Inc., San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193288 is the FDA 510(k) clearance record for Koya Ripple, a class II device, cleared for Koya, Inc. on under FDA product code JOW (Sleeve, Limb, Compressible). FDA records list one 510(k) clearance for Koya, Inc. As of , FDA records show no recalls naming K193288.

Clearance record

Decision date
Received
(202 days to decision)
Product code
JOW Sleeve, Limb, Compressible
Regulation
21 CFR 870.5800
Device class
Class II
Review panel
Cardiovascular
Applicant
Koya, Inc. 357 Tehama St. Suite 1, San Francisco CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOW

Trailing 12 months
8 clearances under product code JOW in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JOW, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20261
May 20260
June 20261
July 20261
August 20261
September 20261
October 20260