Cleared Traditional

BIOCHECK PEC-108 PROGRAM-PULSE MONITOR (K831752) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K831752 · Biotechnology, Inc. · Cardiovascular device
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Sep 1983
Decision
120d
Days
Class 2
Risk

K831752 is an FDA 510(k) clearance for the BIOCHECK PEC-108 PROGRAM-PULSE MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Biotechnology, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Biotechnology, Inc. devices

Submission Details

510(k) Number K831752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1983
Decision Date September 29, 1983
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 68
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K831752.
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