510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K840669Substantially Equivalent

Suction Device-Pharyneal Device

Lipsky-Dale Medical Products, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840669 is the FDA 510(k) clearance record for SUCTION DEVICE-PHARYNEAL DEVICE, a class II device, cleared for Lipsky-Dale Medical Products on under FDA product code JOL (Catheter And Tip, Suction). FDA records list one 510(k) clearance for Lipsky-Dale Medical Products. As of , FDA records show no recalls naming K840669.

Clearance record

Decision date
Received
(132 days to decision)
Product code
JOL Catheter And Tip, Suction
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Lipsky-Dale Medical Products 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JOL

Trailing 12 months

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

FDA records show no clearances under product code JOL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOL, 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