Cleared Traditional

A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 (K101002) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K101002 · Healthstats International Pte. , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
57d
Days
Class 2
Risk

K101002 is an FDA 510(k) clearance for the A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Healthstats International Pte. , Ltd. (Egale, US). The FDA issued a Cleared decision on June 8, 2010 after a review of 57 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Healthstats International Pte. , Ltd. devices

Submission Details

510(k) Number K101002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2010
Decision Date June 08, 2010
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 293
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K101002.
SURESIGNS VS2 VITAL SIGNS MONITOR
K111114 · Philips Medical Systems · May 2011
U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM
K100658 · Taidoc Technology Corporation · Jul 2010
WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES
K101680 · Welch Allyn, Inc. · Jul 2010
WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE
K093907 · Welch Allyn, Inc. · Apr 2010
U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132
K092106 · Taidoc Technology Corporation · Jan 2010
BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019
K091897 · Taidoc Technology Corporation · Aug 2009