Cleared Traditional

K070209 - FB-100U SERIES DIGITAL BLOOD PRESSURE M...

K070209 is the FDA 510(k) clearance for FB-100U SERIES DIGITAL BLOOD PRESSURE M... by Fego Precision Industrial Co;, Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K070209 · Fego Precision Industrial Co;, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
198d
Days
Class 2
Risk

K070209 is an FDA 510(k) clearance for the FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Fego Precision Industrial Co;, Ltd. (Flagstaff, US). The FDA issued a Cleared decision on August 8, 2007 after a review of 198 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 Fego Precision Industrial Co;, Ltd. devices

Submission Details

510(k) Number K070209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2007
Decision Date August 08, 2007
Days to Decision 198 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
73d slower than avg
Panel avg: 125d · This submission: 198d
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 509
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K070209.
CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026
K073445 · Taidoc Technology Corporation · Apr 2008
1500 PRO
K080289 · Omron Healthcare, Inc. · Feb 2008
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1)
K073198 · Microlife Intellectual Property GmbH · Jan 2008
A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR
K062027 · A&D Engineering, Inc. · Jan 2007
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC
K061471 · Microlife Intellectual Property GmbH · Sep 2006
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3
K061822 · Omron Healthcare, Inc. · Aug 2006