Cleared Traditional

K831768 - EXTERNAL PULSE GENERATOR FOR TEMP. STIM

K831768 is an FDA 510(k) clearance for EXTERNAL PULSE GENERATOR FOR TEMP. STIM, manufactured by Oscor, Inc.. The device is a Class 2 Cardiovascular device with product code DTE cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K831768 · Oscor, Inc. · Cardiovascular device
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Dec 1983
Decision
198d
Days
Class 2
Risk

K831768 is an FDA 510(k) clearance for the EXTERNAL PULSE GENERATOR FOR TEMP. STIM. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on December 16, 1983 after a review of 198 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3600 - 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 Oscor, Inc. devices

FDA 510(k) Submission Details - K831768

510(k) Number K831768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1983
Decision Date December 16, 1983
Days to Decision 198 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 125d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTE Device Classification - Class 2, Special Controls

Product Code DTE Pulse-generator, Pacemaker, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3600
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 - DTE Pulse-generator, Pacemaker, External

All 28
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K831768.
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
K910237 · Medtronic Vascular · Feb 1991
MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE
K893633 · Medtronic Vascular · Jun 1989
ERA-20
K853194 · Biotronik Sales, Inc. · Mar 1987
STERILE PACKAGING
K811092 · Telectronics, Inc. · Jul 1981
PACING SYSTEM ANALYZER
K803313 · Medtronic Vascular · Feb 1981
CHRONOCOR IV MODEL 250
K802221 · Cordis Corp. · Nov 1980