DoubleChek DC-1001— 510(k) K212316

Substantially Equivalent

Nasogastric Feeding Solutions, Ltd.

FDA 510(k) clearance K212316 for DoubleChek DC-1001, Substantially Equivalent on 2022-09-30. Applicant: Nasogastric Feeding Solutions, Ltd..

Clearance details

Applicant: Nasogastric Feeding Solutions, Ltd.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2021-07-26
Decision date: 2022-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Liverpool, GB

Download summary PDF View on FDA.gov ↗

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.