510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100899Substantially Equivalent

Olympus Endoscopic Flushing Pump, Model Opf-2

KEYMED (Medical & Industrial Equipment) Ltd, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100899 is the FDA 510(k) clearance record for OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2, a class II device, cleared for Keymed (Medical & Industrial Equipment), Ltd. on under FDA product code FEQ (Pump, Air, Non-Manual, For Endoscope). FDA records list 7 510(k) clearances for Keymed (Medical & Industrial Equipment), Ltd., from to . As of , FDA records show 3 recalls naming K100899.

Clearance record

Decision date
Received
(166 days to decision)
Product code
FEQ Pump, Air, Non-Manual, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Keymed (Medical & Industrial Equipment), Ltd. 11440 W. Bernardo Dr., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FEQ

Trailing 12 months

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

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