Cleared Traditional

K910421 - SATURATION/HEMATOCRIT MONITOR SYSTEM

K910421 is an FDA 510(k) clearance for SATURATION/HEMATOCRIT MONITOR SYSTEM, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K910421

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.

DRY Device Classification - Class 2, Special Controls

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 32
Devices cleared under the same product code (DRY) and FDA review panel - the closest regulatory comparables to K910421.
CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO
K931968 · 3M Health Care, Ltd. · Nov 1993
CDI(TM) 300, 400 & 100, MODIFICATION
K915255 · 3M Company · Jan 1992
CDI(TM) H/S CUVETTE, MODIFICATION
K915265 · 3M Company · Jan 1992
APPLICARD (EKG)
K900459 · Medi-Globe Corp. · Jul 1990
STOCKERT-SHILEY BUBBLE MONITOR 23-23-01
K881006 · Shiley, Inc. · May 1988
STAT-SAT
K874839 · Gish Biomedical, Inc. · May 1988