Cleared Traditional

K922027 - AMBULATORY (HOLTER) RECORDING, MODIFICATION

K922027 is an FDA 510(k) clearance for AMBULATORY (HOLTER) RECORDING, manufactured by Biosensor Corp.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K922027 · Biosensor Corp. · Cardiovascular device
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Feb 1993
Decision
328d
Days
Class 2
Risk

K922027 is an FDA 510(k) clearance for the AMBULATORY (HOLTER) RECORDING, MODIFICATION. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Biosensor Corp. (Minneapolis, US). The FDA issued a Cleared decision on February 17, 1993 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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. Elevated predicate reliance profile. 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 Biosensor Corp. devices

FDA 510(k) Submission Details - K922027

510(k) Number K922027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1992
Decision Date February 17, 1993
Days to Decision 328 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
203d slower than avg
Panel avg: 125d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 275
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K922027.
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