Cleared Traditional

COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC (K902758) - FDA 510(k) Clearance

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

K902758 · Cobe Laboratories, Inc. · Anesthesiology device
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Aug 1990
Decision
59d
Days
Class 2
Risk

K902758 is an FDA 510(k) clearance for the COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Arvada, US). The FDA issued a Cleared decision on August 23, 1990 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cobe Laboratories, Inc. devices

Submission Details

510(k) Number K902758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1990
Decision Date August 23, 1990
Days to Decision 59 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 140d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 248
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K902758.
AP-860PA NIBP MODULE
K910629 · Nihon Kohden America, Inc. · May 1991
COROMETRICS MODEL 556 NEONATAL MONITOR
K900001 · Ge Medical Systems Information Technologies · Nov 1990
HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE
K903523 · Hewlett-Packard Co. · Oct 1990
MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)
K901819 · Hewlett-Packard Co. · Jul 1990
PULSE OXIMETRY MODULE
K901071 · Marquette Electronics, Inc. · Jun 1990
CNS-8200A CENTRAL NURSES STATION
K884050 · Nihon Kohden America, Inc. · Feb 1989