Cleared Traditional

K803208 - SIRECUST 358

K803208 is the FDA 510(k) clearance for SIRECUST 358 by Siemens Corp.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K803208 · Siemens Corp. · Cardiovascular device
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May 1981
Decision
160d
Days
Class 2
Risk

K803208 is an FDA 510(k) clearance for the SIRECUST 358. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Siemens Corp. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981 after a review of 160 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 Siemens Corp. devices

Submission Details

510(k) Number K803208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1980
Decision Date May 27, 1981
Days to Decision 160 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
35d slower than avg
Panel avg: 125d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 233
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K803208.
THE BETA
K810940 · Burdick Corp. · Jul 1981
ARRYTHMIA PRINTER OPTION
K811792 · American Edwards Laboratories · Jul 1981
DEL MAR AVIONICS MODELS 9400 & 9401
K811122 · Del Mar Avionics · Jun 1981
GUARDIAN MONITOR (CARDIOVASCULAR)
K803282 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1981
OXFORD INTENSIVE CARE PATIENT MON. SYS
K802033 · Oxford Medilog, Inc. · Sep 1980
ECG RECALL & EDIT PRODUCT VERSION-A3601
K802103 · General Electric Co. · Sep 1980