Cleared Traditional

K926099 - DATASCOPE 6000 MONITOR

K926099 is an FDA 510(k) clearance for DATASCOPE 6000 MONITOR, manufactured by Datascope Corp.. The device is a Class 2 Cardiovascular device with product code MLC cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K926099 · Datascope Corp. · Cardiovascular device
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Aug 1993
Decision
246d
Days
Class 2
Risk

K926099 is an FDA 510(k) clearance for the DATASCOPE 6000 MONITOR. Classified as Monitor, St Segment (product code MLC), Class II - Special Controls.

Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on August 6, 1993 after a review of 246 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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

FDA 510(k) Submission Details - K926099

510(k) Number K926099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1992
Decision Date August 06, 1993
Days to Decision 246 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
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.

MLC Device Classification - Class 2, Special Controls

Product Code MLC Monitor, St Segment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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.