Cleared Traditional

K903966 - EXTERNAL PACEMAKER ANALYZER MODEL PMA-1

K903966 is an FDA 510(k) clearance for EXTERNAL PACEMAKER ANALYZER MODEL PMA-1, manufactured by Bio-Tek Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DTC cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K903966 · Bio-Tek Instruments, Inc. · Cardiovascular device
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Jun 1991
Decision
295d
Days
Class 2
Risk

K903966 is an FDA 510(k) clearance for the EXTERNAL PACEMAKER ANALYZER MODEL PMA-1. Classified as Analyzer, Pacemaker Generator Function (product code DTC), Class II - Special Controls.

Submitted by Bio-Tek Instruments, Inc. (Winooski, US). The FDA issued a Cleared decision on June 19, 1991 after a review of 295 days - an extended review 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: 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 Bio-Tek Instruments, Inc. devices

FDA 510(k) Submission Details - K903966

510(k) Number K903966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1990
Decision Date June 19, 1991
Days to Decision 295 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
170d slower than avg
Panel avg: 125d · This submission: 295d
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 25
Devices cleared under the same product code (DTC) and FDA review panel - the closest regulatory comparables to K903966.
PK-141 PATIENT CABLE
K083674 · Biotronik, Inc. · Apr 2009
MODEL 4810 ANALYZER OUTPUT ADAPTER
K002497 · Pace Medical · Oct 2000
EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100
K961582 · North American Technical Services Corp. · Nov 1996
MODEL 5311B A-V PACING SYSTEM ANALYZER
K910595 · Medtronic Vascular · May 1991
CPI MODEL 2215/SEAMED MODEL 3400
K910223 · Seamed Corp. · Mar 1991
PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE
K901332 · Biotronik, GmbH & Co. · May 1990