Cleared Traditional

K913805 - MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER

K913805 is an FDA 510(k) clearance for MINIATURE MODELS 4562/4563/4572/4573 PA..., manufactured by Pace Medical. The device is a Class 2 Cardiovascular device with product code DTE cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K913805 · Pace Medical · Cardiovascular device
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Nov 1991
Decision
85d
Days
Class 2
Risk

K913805 is an FDA 510(k) clearance for the MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Pace Medical (Waltham, US). The FDA issued a Cleared decision on November 19, 1991 after a review of 85 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 Pace Medical devices

FDA 510(k) Submission Details - K913805

510(k) Number K913805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1991
Decision Date November 19, 1991
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 54
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K913805.
EXTERNAL DEMAND PACEMAKER
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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