Cleared Traditional

FETALGARD LITE-NIBP, MODEL FGL-NIBP (K051903) - FDA 510(k) Clearance

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

K051903 · Analogic Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
167d
Days
Class 2
Risk

K051903 is an FDA 510(k) clearance for the FETALGARD LITE-NIBP, MODEL FGL-NIBP. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Analogic Corporation (Peabody, US). The FDA issued a Cleared decision on December 27, 2005 after a review of 167 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 Analogic Corporation devices

Submission Details

510(k) Number K051903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2005
Decision Date December 27, 2005
Days to Decision 167 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
42d slower than avg
Panel avg: 125d · This submission: 167d
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 286
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K051903.
BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019
K091897 · Taidoc Technology Corporation · Aug 2009
CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026
K073445 · Taidoc Technology Corporation · Apr 2008
CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250
K061073 · Taidoc Technology Corporation · Jun 2006
IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A
K052872 · Taidoc Technology Corporation · Nov 2005
DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900
K052784 · Welch Allyn, Inc. · Nov 2005
CLEVER TD-3018A BLOOD PRESSURE MONITOR
K051703 · Taidoc Technology Corporation · Aug 2005