Cleared Traditional

K131245 - OREGON SCINTIFIC

K131245 is an FDA 510(k) clearance for OREGON SCINTIFIC, manufactured by Idt Technology Limited. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K131245 · Idt Technology Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
261d
Days
Class 2
Risk

K131245 is an FDA 510(k) clearance for the OREGON SCINTIFIC. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Idt Technology Limited (Shenzhen,, CN). The FDA issued a Cleared decision on January 17, 2014 after a review of 261 days - an extended review 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: 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 Idt Technology Limited devices

FDA 510(k) Submission Details - K131245

510(k) Number K131245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2013
Decision Date January 17, 2014
Days to Decision 261 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 125d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

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 841
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K131245.
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES
K133619 · Grandway Technology (Shenzhen) Limited · Mar 2014
HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE
K131788 · Healthstats International Pte. , Ltd. · Mar 2014
HEM-7320
K133383 · Omron Healthcare, Inc. · Mar 2014
HEM-7311
K133379 · Omron Healthcare, Inc. · Jan 2014
ARM AUTOMATIC BLOOD PRESSURE MONITOR
K130325 · Shenzhen Pump Medical System Co., Ltd. · Dec 2013
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES
K132240 · Grandway Technology (Shenzhen) Limited · Dec 2013