Cleared Traditional

K852250 - 595 ARRHYTHMIA MONITORING SYSTEM

K852250 is an FDA 510(k) clearance for 595 ARRHYTHMIA MONITORING SYSTEM, manufactured by Burdick Corp.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K852250 · Burdick Corp. · Cardiovascular device
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May 1986
Decision
344d
Days
Class 2
Risk

K852250 is an FDA 510(k) clearance for the 595 ARRHYTHMIA MONITORING SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Burdick Corp. (Miltoon, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Burdick Corp. devices

FDA 510(k) Submission Details - K852250

510(k) Number K852250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1985
Decision Date May 02, 1986
Days to Decision 344 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
219d slower than avg
Panel avg: 125d · This submission: 344d
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 234
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K852250.
MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM
K863724 · Oxford Medilog, Inc. · Nov 1986
Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR
K863159 · Quinton, Inc. · Oct 1986
PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III
K860980 · Spacelabs, Inc. · May 1986
SCM-400 HOLTER SYSTEM
K860950 · Fukuda Denshi USA, Inc. · May 1986
DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST
K860470 · Del Mar Avionics · Apr 1986
DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER
K860471 · Del Mar Avionics · Apr 1986