KEITH-A.R.V.— 510(k) K851444

Name: FDA 510(k) clearance K851444
Creator: U.S. Food and Drug Administration
Published: 1985-05-10

Substantially Equivalent

Karl M. Block Co.

FDA 510(k) clearance K851444 for KEITH-A.R.V., Substantially Equivalent on 1985-05-10. Applicant: Karl M. Block Co.. Device class: 2.

Clearance details

Applicant: Karl M. Block Co.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1985-04-11
Decision date: 1985-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNT

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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

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 →

Recalls naming K851444

K-number listed on FDA's recall record

Z-0209-2026 — Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux ValveClass II·Ongoing·Cardinal Health 200, LLC·20250918

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K851444.

Data sourced from openFDA. This site is unofficial and independent of the FDA.