Cleared Traditional

K942072 - MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND

K942072 is an FDA 510(k) clearance for MABIS BRAND AND MABIS CUSTOMERS PRIVATE..., manufactured by Mabis Healthcare, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 376-day FDA review.

K942072 · Mabis Healthcare, Inc. · Cardiovascular device
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May 1995
Decision
376d
Days
Class 2
Risk

K942072 is an FDA 510(k) clearance for the MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Mabis Healthcare, Inc. (Lake Forest, US). The FDA issued a Cleared decision on May 10, 1995 after a review of 376 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mabis Healthcare, Inc. devices

FDA 510(k) Submission Details - K942072

510(k) Number K942072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1994
Decision Date May 10, 1995
Days to Decision 376 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
251d slower than avg
Panel avg: 125d · This submission: 376d
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 781
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