Cleared Traditional

K810027 - DATAMEDIX PECGASYS SYSTEM

K810027 is an FDA 510(k) clearance for DATAMEDIX PECGASYS SYSTEM, manufactured by Datamedix. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K810027 · Datamedix · Cardiovascular device
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Mar 1981
Decision
80d
Days
Class 2
Risk

K810027 is an FDA 510(k) clearance for the DATAMEDIX PECGASYS SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Datamedix (Mchenry, US). The FDA issued a Cleared decision on March 26, 1981 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Datamedix devices

FDA 510(k) Submission Details - K810027

510(k) Number K810027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1981
Decision Date March 26, 1981
Days to Decision 80 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
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 315
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K810027.
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