Cleared Traditional

K132033 - BM3/BM3 PLUS

K132033 is an FDA 510(k) clearance for BM3/BM3 PLUS, manufactured by Noblitt & Rueland. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K132033 · Noblitt & Rueland · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
156d
Days
Class 2
Risk

K132033 is an FDA 510(k) clearance for the BM3/BM3 PLUS. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Noblitt & Rueland (Irvine, US). The FDA issued a Cleared decision on December 4, 2013 after a review of 156 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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.

FDA 510(k) Submission Details - K132033

510(k) Number K132033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2013
Decision Date December 04, 2013
Days to Decision 156 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
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 307
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K132033.
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