510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011725Substantially Equivalent

Olympus Suction Pump, Model Kv-5

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

K011725 is the FDA 510(k) clearance record for OLYMPUS SUCTION PUMP, MODEL KV-5, a class II device, cleared for Keymed (Medical & Industrial Equipment), Ltd. on under FDA product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered). FDA records list 7 510(k) clearances for Keymed (Medical & Industrial Equipment), Ltd., from to . As of , FDA records show no recalls naming K011725.

Clearance record

Decision date
Received
(88 days to decision)
Product code
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Keymed (Medical & Industrial Equipment), Ltd. Stock Rd., Southend-On-Sea, Essex, GB
510(k) summary
Statement
Third party review
No

Clearances, product code JCX

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