Cleared Traditional

K080941 - BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM

K080941 is an FDA 510(k) clearance for BIOIMPEDANCE CARDIAC ANALYZING MEASURIN..., manufactured by N.I. Medical, Ltd.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 441-day FDA review.

K080941 · N.I. Medical, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
441d
Days
Class 2
Risk

K080941 is an FDA 510(k) clearance for the BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by N.I. Medical, Ltd. (Warrington, US). The FDA issued a Cleared decision on June 18, 2009 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

FDA 510(k) Submission Details - K080941

510(k) Number K080941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2008
Decision Date June 18, 2009
Days to Decision 441 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
316d slower than avg
Panel avg: 125d · This submission: 441d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSB Device Classification - Class 2, Special Controls

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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 - DSB Plethysmograph, Impedance

All 108
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K080941.
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K080941 · BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM
Download PDF FDA Summary N.I. Medical, Ltd.