Cleared Traditional

K850822 - CHRONOCOR V EXTERNAL PACER, MODEL 297A

K850822 is an FDA 510(k) clearance for CHRONOCOR V EXTERNAL 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 138-day FDA review.

K850822 · Seamed Corp. · Cardiovascular device
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Jul 1985
Decision
138d
Days
Class 2
Risk

K850822 is an FDA 510(k) clearance for the CHRONOCOR V EXTERNAL PACER, MODEL 297A. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Seamed Corp. (Redmond, US). The FDA issued a Cleared decision on July 16, 1985 after a review of 138 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 - K850822

510(k) Number K850822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1985
Decision Date July 16, 1985
Days to Decision 138 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
13d slower than avg
Panel avg: 125d · This submission: 138d
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 K850822.
MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER
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SEA MED MODEL 6000
K863903 · Seamed Corp. · Dec 1986
SEAMED MODEL 4000
K854648 · Seamed Corp. · Jan 1986
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