Cleared Traditional

K863903 - SEA MED MODEL 6000

K863903 is an FDA 510(k) clearance for SEA MED MODEL 6000, 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 64-day FDA review.

K863903 · Seamed Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1986
Decision
64d
Days
Class 2
Risk

K863903 is an FDA 510(k) clearance for the SEA MED MODEL 6000. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Seamed Corp. (Bothell, US). The FDA issued a Cleared decision on December 10, 1986 after a review of 64 days - a notably fast clearance 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: 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 Seamed Corp. devices

FDA 510(k) Submission Details - K863903

510(k) Number K863903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1986
Decision Date December 10, 1986
Days to Decision 64 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
61d faster than avg
Panel avg: 125d · This submission: 64d
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 K863903.
MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543
K871915 · Pace Medical · Jun 1987
ERA-20
K853194 · Biotronik Sales, Inc. · Mar 1987
MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER
K870323 · Pace Medical · Mar 1987
SEAMED MODEL 4000
K854648 · Seamed Corp. · Jan 1986
CHRONOCOR V EXTERNAL PACER, MODEL 297A
K850822 · Seamed Corp. · Jul 1985
SEAMED 4000
K843777 · Seamed Corp. · Feb 1985