Cleared Traditional

K913110 - PDM-1 DEVICE:CAPD DISINFECTING DEVICE

K913110 is an FDA 510(k) clearance for PDM-1 DEVICE:CAPD DISINFECTING DEVICE, manufactured by Microwave Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DRQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K913110 · Microwave Medical Systems, Inc. · Cardiovascular device
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Oct 1991
Decision
90d
Days
Class 2
Risk

K913110 is an FDA 510(k) clearance for the PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED. Classified as Amplifier And Signal Conditioner, Transducer Signal (product code DRQ), Class II - Special Controls.

Submitted by Microwave Medical Systems, Inc. (Littleton, US). The FDA issued a Cleared decision on October 10, 1991 after a review of 90 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.

View all Microwave Medical Systems, Inc. devices

FDA 510(k) Submission Details - K913110

510(k) Number K913110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1991
Decision Date October 10, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 14
Devices cleared under the same product code (DRQ) and FDA review panel - the closest regulatory comparables to K913110.
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BARD BIOPOTENTIAL AMPLIFIER II
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K864320 · Cordis Corp. · Feb 1987