Cleared Traditional

K930888 - WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM

K930888 is an FDA 510(k) clearance for WRISTRECORDER PLUS CARDIAC EVENT RECORD..., manufactured by Ralin Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K930888 · Ralin Medical, Inc. · Cardiovascular device
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Jul 1993
Decision
152d
Days
Class 2
Risk

K930888 is an FDA 510(k) clearance for the WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Ralin Medical, Inc. (Beaverton, US). The FDA issued a Cleared decision on July 21, 1993 after a review of 152 days - an extended review cycle.

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 Ralin Medical, Inc. devices

FDA 510(k) Submission Details - K930888

510(k) Number K930888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1993
Decision Date July 21, 1993
Days to Decision 152 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
27d slower than avg
Panel avg: 125d · This submission: 152d
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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