MED GRAVITY SET, IMED PUMP SET— 510(k) K102712

Name: FDA 510(k) clearance K102712
Creator: U.S. Food and Drug Administration
Published: 2011-12-16

Substantially Equivalent

Imed Technology, Inc.

FDA 510(k) clearance K102712 for MED GRAVITY SET, IMED PUMP SET, Substantially Equivalent on 2011-12-16. Applicant: Imed Technology, Inc.. Device class: 2.

Clearance details

Applicant: Imed Technology, Inc.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2010-09-20
Decision date: 2011-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, 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 Imed Technology, Inc.

view all

K150513 — Imed Technology Intravascular Administration Set, Imed Technology Extension Set2015-05-28

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.