Cleared Traditional

K912507 - CPI MODEL 2215 & SEAMED MODEL 3400

K912507 is an FDA 510(k) clearance for CPI MODEL 2215 & SEAMED MODEL 3400, 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 89-day FDA review.

K912507 · Seamed Corp. · Cardiovascular device
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Sep 1991
Decision
89d
Days
Class 2
Risk

K912507 is an FDA 510(k) clearance for the CPI MODEL 2215 & SEAMED MODEL 3400. 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 September 3, 1991 after a review of 89 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 - K912507

510(k) Number K912507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1991
Decision Date September 03, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
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 K912507.
CPI MODEL 2215
K923398 · Seamed Corp. · Aug 1992
CHRONOCOR VI MODEL 5012
K915364 · Seamed Corp. · Feb 1992
MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER
K913805 · Pace Medical · Nov 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