Cleared Traditional

K802900 - HEART SENTINEL

K802900 is an FDA 510(k) clearance for HEART SENTINEL, manufactured by Totemite Medical Electronics. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K802900 · Totemite Medical Electronics · Cardiovascular device
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Mar 1981
Decision
114d
Days
Class 2
Risk

K802900 is an FDA 510(k) clearance for the HEART SENTINEL. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Totemite Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on March 11, 1981 after a review of 114 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 Totemite Medical Electronics devices

FDA 510(k) Submission Details - K802900

510(k) Number K802900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1980
Decision Date March 11, 1981
Days to Decision 114 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 125d · This submission: 114d
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 K802900.
ARRYTHMIA PRINTER OPTION
K811792 · American Edwards Laboratories · Jul 1981
DEL MAR AVIONICS MODELS 9400 & 9401
K811122 · Del Mar Avionics · Jun 1981
SIRECUST 358
K803208 · Siemens Corp. · May 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