Cleared Traditional

SCINTISTRESS SYSTEM (K791201) - FDA 510(k) Clearance

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

K791201 · Cambridge Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1979
Decision
81d
Days
Class 2
Risk

K791201 is an FDA 510(k) clearance for the SCINTISTRESS SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cambridge Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1979 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Cambridge Instruments, Inc. devices

Submission Details

510(k) Number K791201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1979
Decision Date September 17, 1979
Days to Decision 81 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 81
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K791201.
CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM
K861359 · Hewlett-Packard Co. · May 1986
ELECTROCARDIOGRAPH CM3000
K813279 · Philips Medical Systems (Cleveland), Inc. · Dec 1981
MODEL 4700A ELECTROCARDIOGRAPH
K802718 · Hewlett-Packard Co. · Nov 1980
MODEL 78501A PATIENT MONITORING SYSTEM
K790939 · Hewlett-Packard Co. · Jun 1979
ELAPSED TIME INDICATOR MODEL 21361A
K771380 · Hewlett-Packard Co. · Nov 1977
MONITOR, PORTABLE, PATIENT, G.E.
K770760 · General Electric Co. · May 1977