INFECTION CONTROL VALVE— 510(k) K841480

Name: FDA 510(k) clearance K841480
Creator: U.S. Food and Drug Administration
Published: 1984-04-25

Substantially Equivalent

Superior Plastic Products Corp.

FDA 510(k) clearance K841480 for INFECTION CONTROL VALVE, Substantially Equivalent on 1984-04-25. Applicant: Superior Plastic Products Corp.. Device class: 1.

Clearance details

Applicant: Superior Plastic Products Corp.
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 1984-04-09
Decision date: 1984-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K841945 — ENTERAL FEEDING BOTTLE1984-07-26
K841630 — ENTERAL NUTRITION PUMP1984-06-07
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Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.