Cleared Traditional

K900220 - TRANS-PACE 100

K900220 is an FDA 510(k) clearance for TRANS-PACE 100, manufactured by Synchromed Corp.. The device is a Class 2 Cardiovascular device with product code DTE cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K900220 · Synchromed Corp. · Cardiovascular device
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Jul 1990
Decision
181d
Days
Class 2
Risk

K900220 is an FDA 510(k) clearance for the TRANS-PACE 100. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Synchromed Corp. (Cape Coral, US). The FDA issued a Cleared decision on July 17, 1990 after a review of 181 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 Synchromed Corp. devices

FDA 510(k) Submission Details - K900220

510(k) Number K900220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1990
Decision Date July 17, 1990
Days to Decision 181 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 125d · This submission: 181d
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 55
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K900220.
CPI MODEL 2215 & SEAMED MODEL 3400
K912507 · Seamed Corp. · Sep 1991
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
K910237 · Medtronic Vascular · Feb 1991
MODELS 4201, 4231 & 4235 EXTENSION CABLES
K902679 · Pace Medical · Jul 1990
MODEL EC4542G MINIATURE
K896352 · Pace Medical · Jan 1990
MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE
K893633 · Medtronic Vascular · Jun 1989
SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY
K883930 · Seamed Corp. · Nov 1988