Cleared Traditional

K904749 - TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200

K904749 is an FDA 510(k) clearance for TRANSKINETICS RADO FREQ MULTI-LEAD TELE..., manufactured by Transtracheal Systems. The device is a Class 2 Cardiovascular device with product code DRQ cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K904749 · Transtracheal Systems · Cardiovascular device
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Mar 1991
Decision
133d
Days
Class 2
Risk

K904749 is an FDA 510(k) clearance for the TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200. Classified as Amplifier And Signal Conditioner, Transducer Signal (product code DRQ), Class II - Special Controls.

Submitted by Transtracheal Systems (Canton, US). The FDA issued a Cleared decision on March 1, 1991 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2060 - 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.

FDA 510(k) Submission Details - K904749

510(k) Number K904749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1990
Decision Date March 01, 1991
Days to Decision 133 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
8d slower than avg
Panel avg: 125d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRQ Device Classification - Class 2, Special Controls

Product Code DRQ Amplifier And Signal Conditioner, Transducer Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2060
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 - DRQ Amplifier And Signal Conditioner, Transducer Signal

All 20
Devices cleared under the same product code (DRQ) and FDA review panel - the closest regulatory comparables to K904749.
BARD(R) BIOPOTENTIAL AMPLIFIER II
K913875 · Bard Electrophysiology · Nov 1991
PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED
K913110 · Microwave Medical Systems, Inc. · Oct 1991
SFA-II MICROPROCESSOR-CONTROLLED MODULE
K910905 · Life Sciences Manufacturing, Inc. · Jul 1991
BARD BIOPOTENTIAL AMPLIFIER II
K901358 · C.R. Bard, Inc. · May 1990
ASTRO-MED ASC-951 PRESSURE PROCESSOR
K894295 · Astro-Med, Inc. · Jan 1990
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701
K870728 · A&D Engineering, Inc. · Mar 1987
K904749 · TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200
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