Cleared Traditional

K091430 - CARE PAL, MODEL CPW-10X (FDA 510(k) Clearance)

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

K091430 · Digio2 International Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
99d
Days
Class 2
Risk

K091430 is an FDA 510(k) clearance for the CARE PAL, MODEL CPW-10X. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Digio2 International Co., Ltd. (Flagstaff, US). The FDA issued a Cleared decision on August 21, 2009 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Digio2 International Co., Ltd. devices

Submission Details

510(k) Number K091430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2009
Decision Date August 21, 2009
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 190
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K091430.
Perin Health System (PHD80060-2)
K252984 · Perin Health Devices, LLC · Jan 2026
EasyTeleMed (2.0.2)
K252440 · Ingeniars S.R.L. · Oct 2025
TeleRehab Aermos Cardiopulmonary Rehabilitation
K250259 · The ScottCare Corporation · Jun 2025
iBSM
K243837 · Iorbit Digital Technologies Private Limited · May 2025
UbiqVue™ 2A Multi-parameter System (UX2550)
K242018 · Lifesignals, Inc. · Nov 2024
BioButton System
K241101 · Biointellisense, Inc. · Sep 2024