OLYMPUS SUCTION PUMP, MODEL KV-5— 510(k) K011725

Name: FDA 510(k) clearance K011725
Creator: U.S. Food and Drug Administration
Published: 2001-08-31

Substantially Equivalent

Keymed (Medical & Industrial Equipment), Ltd.

FDA 510(k) clearance K011725 for OLYMPUS SUCTION PUMP, MODEL KV-5, Substantially Equivalent on 2001-08-31. Applicant: Keymed (Medical & Industrial Equipment), Ltd.. Device class: 2.

Clearance details

Applicant: Keymed (Medical & Industrial Equipment), Ltd.
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2001-06-04
Decision date: 2001-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southend-On-Sea, Essex, GB

Download summary PDF View on FDA.gov ↗

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K962528 — OLYMPUS MOBILE CHAIR/COUCH1996-12-12
K930852 — OLYMPUS SUCTION PUMP MODEL KV-41994-03-31
K881478 — MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS1988-09-14

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.