Cleared Abbreviated

K010186 - WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM

K010186 is the FDA 510(k) clearance for WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM by Welch Allyn, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Abbreviated 510(k) pathway after a 137-day FDA review.

K010186 · Welch Allyn, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
137d
Days
Class 2
Risk

K010186 is an FDA 510(k) clearance for the WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Arden, US). The FDA issued a Cleared decision on June 8, 2001 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Welch Allyn, Inc. devices

Submission Details

510(k) Number K010186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2001
Decision Date June 08, 2001
Days to Decision 137 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 125d · This submission: 137d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 508
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K010186.
HL168E
K014122 · Health & Life Co., Ltd. · Jan 2002
MODIFICATION TO: HL168W TOUCH SCREEN
K013033 · Health & Life Co., Ltd. · Oct 2001
MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
K012310 · Health & Life Co., Ltd. · Aug 2001
BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520
K001543 · Welch Allyn, Inc. · Jan 2001
WELCH ALLYN SPOT CHECK DEVICE
K002530 · Welch Allyn, Inc. · Nov 2000
HL168B
K002882 · Health & Life Co., Ltd. · Oct 2000