Cleared Traditional

K884216 - 506 NON-INVASIVE VITAL SIGNS MONITOR

K884216 is an FDA 510(k) clearance for 506 NON-INVASIVE VITAL SIGNS MONITOR, manufactured by Criticare Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K884216 · Criticare Systems, Inc. · Cardiovascular device
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Mar 1989
Decision
161d
Days
Class 2
Risk

K884216 is an FDA 510(k) clearance for the 506 NON-INVASIVE VITAL SIGNS MONITOR. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Criticare Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on March 16, 1989 after a review of 161 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Criticare Systems, Inc. devices

FDA 510(k) Submission Details - K884216

510(k) Number K884216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1988
Decision Date March 16, 1989
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 125d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 245
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K884216.
HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)
K885204 · Mennen Medical, Inc. · Apr 1989
MEDILOG EDITOR
K890338 · Oxford Medilog, Inc. · Apr 1989
SUPERMON ARRHYTHMIA MODULE 7270
K882206 · Kontron Instruments, Inc. · Apr 1989
SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL
K884106 · Siemens Medical Solutions USA, Inc. · Mar 1989
MODEL 499 SSR ANALYSIS SYSTEM
K884887 · Del Mar Avionics · Feb 1989
E550 ELECTROCARDIOGRAPH
K883440 · Burdick Corp. · Jan 1989