Cleared Traditional

K213233 - EZYPRO ECG Recorder (Model: UG02)

K213233 is an FDA 510(k) clearance for EZYPRO ECG Recorder (Model: UG02), manufactured by Sigknow Biomedical Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K213233 · Sigknow Biomedical Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
266d
Days
Class 2
Risk

K213233 is an FDA 510(k) clearance for the EZYPRO ECG Recorder (Model: UG02). Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Sigknow Biomedical Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on June 23, 2022 after a review of 266 days - an extended review cycle.

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 Sigknow Biomedical Co., Ltd. devices

FDA 510(k) Submission Details - K213233

510(k) Number K213233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2021
Decision Date June 23, 2022
Days to Decision 266 days
Submission Type Traditional
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
141d slower than avg
Panel avg: 125d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRG Device Classification - Class 2, Special Controls

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 73
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K213233.
BioButton System
K212957 · Biolntellisense, Inc. · Dec 2022
ANNE Pediatric
K221530 · Sibel, Inc. · Nov 2022
ers2 - ergoline Rehabilitation System
K212883 · Ergoline GmbH · Jul 2022
Alio Medical Remote Monitoring System
K211365 · Graftworx, Inc. Dba Alio · Mar 2022
LifePath Remote Patient Monitoring Platform
K211822 · Elastic Care Incorporated · Feb 2022
ANNE One
K211305 · Sibel, Inc. · Sep 2021