Cleared Traditional

K802113 - SIRECUST 400 SYSTEM PATIENT MONITORING

K802113 is an FDA 510(k) clearance for SIRECUST 400 SYSTEM PATIENT MONITORING, manufactured by Analogic Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K802113 · Analogic Corp. · Cardiovascular device
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Jan 1981
Decision
141d
Days
Class 2
Risk

K802113 is an FDA 510(k) clearance for the SIRECUST 400 SYSTEM PATIENT MONITORING. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Analogic Corp. (Mchenry, US). The FDA issued a Cleared decision on January 22, 1981 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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

FDA 510(k) Submission Details - K802113

510(k) Number K802113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1980
Decision Date January 22, 1981
Days to Decision 141 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
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 417
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K802113.
ECG FUNCTION BLOCK
K810176 · Honeywell, Inc. · Feb 1981
MICROPROCESSOR CONTROLLED ELECTROCARDIO
K810263 · Honeywell, Inc. · Feb 1981
ECG ARRHYTHMIA STIMULATOR
K810104 · Belmont Instrument Corp. · Jan 1981
VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH
K803309 · Advanced Technology Laboratories, Inc. · Jan 1981
MODEL 4700A ELECTROCARDIOGRAPH
K802718 · Hewlett-Packard Co. · Nov 1980
MODEL 633A THREE CHANNEL STRESS TEST
K802190 · Quinton, Inc. · Oct 1980