KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)— 510(k) K253001

Name: FDA 510(k) clearance K253001
Creator: U.S. Food and Drug Administration
Published: 2026-06-16

Substantially Equivalent

Hunan Ruijiong Biotech Co., Ltd.

FDA 510(k) clearance K253001 for KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5), Substantially Equivalent on 2026-06-16. Applicant: Hunan Ruijiong Biotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hunan Ruijiong Biotech Co., Ltd.
Product code: Code NHJ
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2025-09-19
Decision date: 2026-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiangtan, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHJ

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Adverse events under product code NHJ

product code NHJ

Death: 7
Total: 7

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.