Cleared Traditional

COMPASS VASCULAR ACCESS (K101518) - FDA 510(k) Clearance

Also marketed or referenced as:
COMPASS LUMBAR PUNCTURE

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K101518 · Mirador Biomedical, Inc. · Cardiovascular device
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Oct 2010
Decision
133d
Days
Class 2
Risk

K101518 is an FDA 510(k) clearance for the COMPASS VASCULAR ACCESS. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Mirador Biomedical, Inc. (Seattle, US). The FDA issued a Cleared decision on October 13, 2010 after a review of 133 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 Mirador Biomedical, Inc. devices

Submission Details

510(k) Number K101518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2010
Decision Date October 13, 2010
Days to Decision 133 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 125d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 147
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