WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)— 510(k) K070060

Name: FDA 510(k) clearance K070060
Creator: U.S. Food and Drug Administration
Published: 2007-12-18

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K070060 for WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE), Substantially Equivalent on 2007-12-18. Applicant: Welch Allyn, Inc.. Device class: 2.

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code DXQ
Device class: Class 2
Regulation: 21 CFR 870.1120
Advisory panel: Cardiovascular
Date received: 2007-01-05
Decision date: 2007-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skaneateles Falls, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K070060

K-number listed on FDA's recall record

Z-1568-2025 — Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Part Numbers: 2. WELCH ALLYN Reusable Blood Pressure Cuff Kit, Product Code/Part Numbers: 410519, 5090-41, 5098-20.Class II·Ongoing·Baxter Healthcare Corporation·20250321

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070060.

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