Cleared Traditional

K910421 - SATURATION/HEMATOCRIT MONITOR SYSTEM

K910421 is the FDA 510(k) clearance for SATURATION/HEMATOCRIT MONITOR SYSTEM by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DRY) cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K910421 · Medtronic Vascular · Cardiovascular device
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Oct 1991
Decision
258d
Days
Class 2
Risk

K910421 is an FDA 510(k) clearance for the SATURATION/HEMATOCRIT MONITOR SYSTEM. Classified as Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (product code DRY), Class II - Special Controls.

Submitted by Medtronic Vascular (Anaheim, US). The FDA issued a Cleared decision on October 15, 1991 after a review of 258 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4330 - 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 Medtronic Vascular devices

Submission Details

510(k) Number K910421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1991
Decision Date October 15, 1991
Days to Decision 258 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
133d slower than avg
Panel avg: 125d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4330
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 - DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

All 20
Devices cleared under the same product code (DRY) and FDA review panel - the closest regulatory comparables to K910421.
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