MPS ACACIA ENTERAL FEEDING TUBE— 510(k) K080328

Name: FDA 510(k) clearance K080328
Creator: U.S. Food and Drug Administration
Published: 2008-05-14

Substantially Equivalent

Mps Acacia

FDA 510(k) clearance K080328 for MPS ACACIA ENTERAL FEEDING TUBE, Substantially Equivalent on 2008-05-14. Applicant: Mps Acacia. Device class: 2.

Clearance details

Applicant: Mps Acacia
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2008-02-07
Decision date: 2008-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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K052451 — MPS ACACIA MEDFLO ELASTOMERIC PUMP2005-12-08
K052946 — MPS ACACIA NERVE BLOCK NEEDLE2005-12-08
K032934 — MPS ACACIA SAFEGUARD HUBER DEVICE2003-11-13
K011117 — MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS2001-07-09

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.