Cleared Traditional

K831752 - BIOCHECK PEC-108 PROGRAM-PULSE MONITOR

K831752 is an FDA 510(k) clearance for BIOCHECK PEC-108 PROGRAM-PULSE MONITOR, manufactured by Biotechnology, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 120-day FDA review.

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

FDA 510(k) Submission Details - K831752

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.

DRT Device Classification - Class 2, Special Controls

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 228
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K831752.
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