LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET— 510(k) K011341

Name: FDA 510(k) clearance K011341
Creator: U.S. Food and Drug Administration
Published: 2001-09-21

Substantially Equivalent

Lh Medical Products, Inc.

FDA 510(k) clearance K011341 for LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET, Substantially Equivalent on 2001-09-21. Applicant: Lh Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Lh Medical Products, Inc.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2001-05-02
Decision date: 2001-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Dimas, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Lh Medical Products, Inc.

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K011340 — LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT2001-09-21
K011343 — LH 500 ENTERAL FEEDING GRAVITY BAG SET2001-09-21

Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.