Cleared Traditional

INSTA-PULSE HEART RATE MONITOR (K781387) - FDA 510(k) Clearance

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

K781387 · Bio Sig Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1978
Decision
41d
Days
Class 2
Risk

K781387 is an FDA 510(k) clearance for the INSTA-PULSE HEART RATE MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Bio Sig Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1978 after a review of 41 days - a notably fast clearance cycle.

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: 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 Bio Sig Instruments, Inc. devices

Submission Details

510(k) Number K781387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1978
Decision Date September 20, 1978
Days to Decision 41 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 125d · This submission: 41d
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 41
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K781387.
RESIDENT BEDSIDE MONITOR
K811216 · Abbott Laboratories · Jul 1981
PDS COMPUTER UNIT/VIDEO TERMINAL
K801761 · General Electric Co. · Aug 1980
MODEL 78801A PATIENT MONITORS
K790454 · Hewlett-Packard Co. · Apr 1979
ECG SCOPE MODEL 7833
K771360 · Hewlett-Packard Co. · Aug 1977
MONITOR, NEONATAL, MODEL 78261A
K770022 · Hewlett-Packard Co. · Feb 1977
MONITOR, NEONATE, MODEL 78213A
K770023 · Hewlett-Packard Co. · Feb 1977