Cleared Special

K010622 - PRESSURE TRAK

K010622 is the FDA 510(k) clearance for PRESSURE TRAK by Suntech Medical Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 27-day FDA review.

K010622 · Suntech Medical Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
27d
Days
Class 2
Risk

K010622 is an FDA 510(k) clearance for the PRESSURE TRAK, MODEL 222-B. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Suntech Medical Instruments, Inc. (Raleigh, US). The FDA issued a Cleared decision on March 29, 2001 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Suntech Medical Instruments, Inc. devices

Submission Details

510(k) Number K010622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2001
Decision Date March 29, 2001
Days to Decision 27 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 520
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K010622.
MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
K012310 · Health & Life Co., Ltd. · Aug 2001
LIFESOURCE MODELS UA-787, UA 787PC, UA-787T
K012013 · A&D Engineering, Inc. · Jul 2001
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
K010186 · Welch Allyn, Inc. · Jun 2001
DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP
K010828 · A&D Engineering, Inc. · Mar 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