Cleared Traditional

K770832 - PORTASCOPE II

K770832 is the FDA 510(k) clearance for PORTASCOPE II by Mennen Greatbatch Electonics. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K770832 · Mennen Greatbatch Electonics · Cardiovascular device
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Jun 1977
Decision
28d
Days
Class 2
Risk

K770832 is an FDA 510(k) clearance for the PORTASCOPE II. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Mennen Greatbatch Electonics (Mchenry, US). The FDA issued a Cleared decision on June 3, 1977 after a review of 28 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 Mennen Greatbatch Electonics devices

Submission Details

510(k) Number K770832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1977
Decision Date June 03, 1977
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
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 266
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K770832.
STRESS TEST SYSTEM
K780166 · Quinton, Inc. · Feb 1978
EK-670
K780138 · Burdick Corp. · Feb 1978
ELAPSED TIME INDICATOR MODEL 21361A
K771380 · Hewlett-Packard Co. · Nov 1977
MONITOR, PORTABLE, PATIENT, G.E.
K770760 · General Electric Co. · May 1977
ELECTROCARDIOGRAPH, EK-7 (3-CHANNELS)
K760271 · Burdick Corp. · Nov 1976
ELECTROCARDIOGRAPH EK-6 W/OPTIONAL CIRC.
K760268 · Burdick Corp. · Nov 1976