FRENTA(R) DUO-SET— 510(k) K895246

Name: FDA 510(k) clearance K895246
Creator: U.S. Food and Drug Administration
Published: 1990-05-02

Substantially Equivalent

Delmed, Inc.

FDA 510(k) clearance K895246 for FRENTA(R) DUO-SET, Substantially Equivalent on 1990-05-02. Applicant: Delmed, Inc.. Device class: 2.

Clearance details

Applicant: Delmed, Inc.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1989-08-21
Decision date: 1990-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Brunswick, NJ, US

Download summary PDF View on FDA.gov ↗

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K895142 — ENTERAL PUMP SET WITH ENTERAL SPIKE1990-10-02
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K895650 — ENTERAL PUMP SET W/ENTERA-FLO SPIKE1990-10-02
K894506 — ENTERA-FLO ENTERAL FEEDING PUMP1990-08-06
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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.