510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000948Substantially Equivalent

Olympus Endoscopic Flushing Pump Model Ofp-1

KEYMED (Medical & Industrial Equipment) Ltd, Southend-On-Sea, Essex, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000948 is the FDA 510(k) clearance record for OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1, 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 one recall naming K000948.

Clearance record

Decision date
Received
(50 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. Stock Rd., Southend-On-Sea, Essex, GB
510(k) summary
Statement
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