Cleared Traditional

K003999 - AVIVA SYSTEM, MODEL SL 2020

Also marketed or referenced as:
AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010

K003999 is an FDA 510(k) clearance for AVIVA SYSTEM, manufactured by American Telecare, Inc.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K003999 · American Telecare, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
184d
Days
Class 2
Risk

K003999 is an FDA 510(k) clearance for the AVIVA SYSTEM, MODEL SL 2020. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by American Telecare, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on June 28, 2001 after a review of 184 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.

View all American Telecare, Inc. devices

FDA 510(k) Submission Details - K003999

510(k) Number K003999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2000
Decision Date June 28, 2001
Days to Decision 184 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
59d slower than avg
Panel avg: 125d · This submission: 184d
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 201
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K003999.
MODIFICATION TO M2376A DEVICELINK SYSTEM
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