Cleared Traditional

K823334 - PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630

K823334 is an FDA 510(k) clearance for PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630, manufactured by Psitron. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K823334 · Psitron · Cardiovascular device
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Mar 1983
Decision
136d
Days
Class 2
Risk

K823334 is an FDA 510(k) clearance for the PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Psitron (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - 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 Psitron devices

FDA 510(k) Submission Details - K823334

510(k) Number K823334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1982
Decision Date March 24, 1983
Days to Decision 136 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 125d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRS Device Classification - Class 2, Special Controls

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 - DRS Transducer, Blood-pressure, Extravascular

All 105
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