Cleared Traditional

K873533 - SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE

K873533 is an FDA 510(k) clearance for SIEMENS SIRECUST 1280, manufactured by Medical Electronics Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K873533 · Medical Electronics Laboratories, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1988
Decision
150d
Days
Class 2
Risk

K873533 is an FDA 510(k) clearance for the SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Medical Electronics Laboratories, Inc. (Danvers, US). The FDA issued a Cleared decision on January 29, 1988 after a review of 150 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 Medical Electronics Laboratories, Inc. devices

FDA 510(k) Submission Details - K873533

510(k) Number K873533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1987
Decision Date January 29, 1988
Days to Decision 150 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 125d · This submission: 150d
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 313
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K873533.
MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)
K880664 · Mortara Instrument, Inc. · Mar 1988
KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM
K870816 · Kontron Instruments, Inc. · Mar 1988
RHYTHMSCAN
K871572 · Brentwood Instruments, Inc. · Feb 1988
CARDIOFAX-V ECG-8110A
K873874 · Nihon Kohden America, Inc. · Jan 1988
FUKUDA DENSHI MODEL FCP-231
K874768 · Fukuda Denshi USA, Inc. · Dec 1987
MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM
K873680 · Oxford Medilog, Inc. · Nov 1987