Cleared Traditional

K810604 - ELECTRODE/PACER SYSTEM ANALYZER PMA 400

K810604 is an FDA 510(k) clearance for ELECTRODE/PACER SYSTEM ANALYZER PMA 400, manufactured by Telectronics, Inc.. The device is a Class 2 Cardiovascular device with product code DTC cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K810604 · Telectronics, Inc. · Cardiovascular device
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Apr 1981
Decision
39d
Days
Class 2
Risk

K810604 is an FDA 510(k) clearance for the ELECTRODE/PACER SYSTEM ANALYZER PMA 400. Classified as Analyzer, Pacemaker Generator Function (product code DTC), Class II - Special Controls.

Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1981 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3630 - 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 Telectronics, Inc. devices

FDA 510(k) Submission Details - K810604

510(k) Number K810604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1981
Decision Date April 14, 1981
Days to Decision 39 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
86d faster than avg
Panel avg: 125d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTC Device Classification - Class 2, Special Controls

Product Code DTC Analyzer, Pacemaker Generator Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3630
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 - DTC Analyzer, Pacemaker Generator Function

All 17
Devices cleared under the same product code (DTC) and FDA review panel - the closest regulatory comparables to K810604.
MEDTRONIC 5311 PACING SYSTEM ANALYZER
K850077 · Medtronic Vascular · Jul 1985
CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)
K844969 · Cordis Corp. · May 1985
MEDTRONIC A-V PACING SYSTEM ANALYZER
K812262 · Medtronic Vascular · Jun 1982
SUSI II PACEMAKER SURVEILLANCE MONITOR
K792602 · Ela Medical, Inc. · Mar 1980
PACING SYSTEM ANALYZER PSA SCE-22
K791975 · Ela Medical, Inc. · Jan 1980
MODEL 674 PACER ANALYZER
K792074 · Del Mar Avionics · Dec 1979