Cleared Traditional

K844791 - SYSTEM SIRECUST 400 SIEMENS SIRECUST 45...

K844791 is the FDA 510(k) clearance for SYSTEM SIRECUST 400 SIEMENS SIRECUST 45... by Analogic Corp.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K844791 · Analogic Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
121d
Days
Class 2
Risk

K844791 is an FDA 510(k) clearance for the SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Analogic Corp. (Peabody, US). The FDA issued a Cleared decision on April 10, 1985 after a review of 121 days - within the typical 510(k) review window.

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 Analogic Corp. devices

Submission Details

510(k) Number K844791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1984
Decision Date April 10, 1985
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
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 231
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K844791.
MEDILOG M3
K852883 · Oxford Medilog, Inc. · Jul 1985
MEDILOG M1
K852884 · Oxford Medilog, Inc. · Jul 1985
OXFORD VDT-40 DISPLAY TERMINAL
K852207 · Oxford Medilog, Inc. · Jun 1985
FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES
K850897 · Fukuda Denshi USA, Inc. · Apr 1985
ARRHYTHMIA SYSTEM AC-11
K841084 · Fukuda Denshi USA, Inc. · Feb 1985
HORIZON ECG SYSTEM
K823844 · Beckman Instruments, Inc. · Jan 1985