Cleared Traditional

K842538 - ACCUTORR CSM SYSTEM

K842538 is the FDA 510(k) clearance for ACCUTORR CSM SYSTEM by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K842538 · Datascope Corp. · Cardiovascular device
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Mar 1985
Decision
246d
Days
Class 2
Risk

K842538 is an FDA 510(k) clearance for the ACCUTORR CSM SYSTEM. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1985 after a review of 246 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Datascope Corp. devices

Submission Details

510(k) Number K842538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1984
Decision Date March 01, 1985
Days to Decision 246 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
121d slower than avg
Panel avg: 125d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 492
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K842538.
MODEL 9300 TREND ANALYZING BIO-MONITOR SYS
K844252 · Medtronic Vascular · Jun 1985
PHYSIOLOGICAL MONITOR 2100
K844353 · Datascope Corp. · Apr 1985
DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX
K844839 · Critikon Company, LLC · Apr 1985
MUSE-DP
K840932 · Marquette Electronics, Inc. · Oct 1984
NON-INVASIVE BP MODULE 7000
K841336 · Marquette Electronics, Inc. · Oct 1984
DRAGER SPHYGMOMED
K840162 · Draeger Medical, Inc. · May 1984