Cleared Traditional

K010770 - BCI ADVISOR VITAL SIGNS MONITOR (9200)

K010770 is an FDA 510(k) clearance for BCI ADVISOR VITAL SIGNS MONITOR (9200), manufactured by Bci, Inc.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K010770 · Bci, Inc. · Cardiovascular device
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Jun 2001
Decision
90d
Days
Class 2
Risk

K010770 is an FDA 510(k) clearance for the BCI ADVISOR VITAL SIGNS MONITOR (9200). Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Bci, Inc. (Waukesha, US). The FDA issued a Cleared decision on June 12, 2001 after a review of 90 days - within the typical 510(k) review window.

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.

View all Bci, Inc. devices

FDA 510(k) Submission Details - K010770

510(k) Number K010770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2001
Decision Date June 12, 2001
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 228
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K010770.
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K013470 · Philips Medical Systems, Inc. · Nov 2001
8100/8500 VITAL SIGNS MONITOR
K012059 · Criticare Systems, Inc. · Aug 2001
MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A
K012094 · Agilent Technologies, Inc. · Jul 2001
M2376A DEVICELINK SYSTEM, MODEL M2376A
K011578 · Agilent Technologies, Inc. · Jun 2001
M2376A DEVICELINK SYSTEM
K010453 · Agilent Technologies, Inc. · Mar 2001
M2376A DEVICELINK SYSTEM, MODEL M2376A
K010342 · Agilent Technologies, Inc. · Feb 2001