Cleared Traditional

K831381 - RAPID ATRIAL PACER

K831381 is an FDA 510(k) clearance for RAPID ATRIAL PACER, manufactured by Seamed Corp.. The device is a Class 2 Cardiovascular device with product code DTE cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K831381 · Seamed Corp. · Cardiovascular device
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Aug 1983
Decision
125d
Days
Class 2
Risk

K831381 is an FDA 510(k) clearance for the RAPID ATRIAL PACER. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Seamed Corp. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1983 after a review of 125 days - within the typical 510(k) review window.

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 Seamed Corp. devices

FDA 510(k) Submission Details - K831381

510(k) Number K831381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1983
Decision Date August 31, 1983
Days to Decision 125 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
At panel average
Panel avg: 125d · This submission: 125d
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 51
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K831381.
SEAMED 4000
K843777 · Seamed Corp. · Feb 1985
SEAMED MODEL 6000
K843807 · Seamed Corp. · Feb 1985
EXTERNAL PULSE GENERATOR FOR TEMP. STIM
K831768 · Oscor, Inc. · Dec 1983
SEA MED MODEL 880
K823048 · Seamed Corp. · Dec 1982
SEAMED, #540 - SIEMENS, #146F TELECTRO
K820570 · Seamed Corp. · Jun 1982
STERILE PACKAGING
K811092 · Telectronics, Inc. · Jul 1981