HOSPIRA ENTERAL FEEDING SET, MODEL 20640— 510(k) K061432

Name: FDA 510(k) clearance K061432
Creator: U.S. Food and Drug Administration
Published: 2006-09-11

Substantially Equivalent

Hospira, Inc.

FDA 510(k) clearance K061432 for HOSPIRA ENTERAL FEEDING SET, MODEL 20640, Substantially Equivalent on 2006-09-11. Applicant: Hospira, Inc.. Device class: 2.

Clearance details

Applicant: Hospira, Inc.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2006-05-24
Decision date: 2006-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, IL, 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 Hospira, Inc.

view all

K161469 — Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module2017-03-28
K161036 — Hospira Extension Set, Hospira Primary Set2017-01-06
K160492 — Hospira Sapphire Sets2016-12-06
K160870 — Hospira Administration Sets2016-06-01
K143612 — LifeCare PCA Infusion System2016-04-08

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.