AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE— 510(k) K992719

Name: FDA 510(k) clearance K992719
Creator: U.S. Food and Drug Administration
Published: 2000-01-12

Substantially Equivalent

Amsino Intl., Inc.

FDA 510(k) clearance K992719 for AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE, Substantially Equivalent on 2000-01-12. Applicant: Amsino Intl., Inc.. Device class: 2.

Clearance details

Applicant: Amsino Intl., Inc.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1999-08-12
Decision date: 2000-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNT

view all

K261890 — 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®2026-08-14
K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more2026-07-10
K250389 — XNY Disposable Gastric Calibration Tube2025-04-10
K243228 — Flexi-Seal AIR (with ENFit Connector)2025-03-28
K242336 — hygh-tec Drainage II2025-01-17

More clearances from Amsino Intl., Inc.

view all

K070873 — AMSURE BLADDER IRRIGATION SET2007-12-19
K974042 — AMSURE CLEANSING ENEMA SET1997-12-19
K973107 — AMSINO I.V. ADMINISTRATION SET1997-10-02
K973199 — AMSINO SUCTION CATHETER1997-09-10
K971929 — AMSINO URINARY LEG BAG1997-08-06

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.