Cleared Traditional

K904336 - NEW COBE SATURATION/HEMATOCRIT MONITOR

K904336 is an FDA 510(k) clearance for NEW COBE SATURATION/HEMATOCRIT MONITOR, manufactured by Cobe Laboratories, Inc.. The device is a Class 2 Hematology device with product code GKF cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K904336 · Cobe Laboratories, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
98d
Days
Class 2
Risk

K904336 is an FDA 510(k) clearance for the NEW COBE SATURATION/HEMATOCRIT MONITOR. Classified as Instrument, Hematocrit, Automated (product code GKF), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Arvada, US). The FDA issued a Cleared decision on December 27, 1990 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5600 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cobe Laboratories, Inc. devices

FDA 510(k) Submission Details - K904336

510(k) Number K904336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1990
Decision Date December 27, 1990
Days to Decision 98 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 113d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKF Device Classification - Class 2, Special Controls

Product Code GKF Instrument, Hematocrit, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5600
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 Hematology devices follow this clearance model.

Regulatory Peers - GKF Instrument, Hematocrit, Automated

All 9
Devices cleared under the same product code (GKF) and FDA review panel - the closest regulatory comparables to K904336.
STAT PROFILE M ANALYZER
K981427 · Nova Biomedical Corp. · May 1998
MARATHON 6K GENERAL-PURPOSE CENTRIFUGE
K915825 · Fisher Scientific Co., LLC · Mar 1992
MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE
K915441 · Fisher Scientific Co., LLC · Jan 1992
SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE
K864646 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1987
STAT-CRIT HEMATOCRIT MEASURING INSTRU
K802199 · United States Surgical, A Division of Tyco Healthc · Feb 1981
CUTTER/COMPUR MINI CENTRIFUGE
K781059 · Cutter Laboratories, Inc. · Aug 1978