Cleared Traditional

504US PULSE OXIMETER (K910770) - FDA 510(k) Clearance

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

K910770 · Criticare Systems, Inc. · Anesthesiology device
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May 1991
Decision
81d
Days
Class 2
Risk

K910770 is an FDA 510(k) clearance for the 504US PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Criticare Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on May 14, 1991 after a review of 81 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 Criticare Systems, Inc. devices

Submission Details

510(k) Number K910770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1991
Decision Date May 14, 1991
Days to Decision 81 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 140d · This submission: 81d
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 184
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K910770.
MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
K923682 · Hewlett-Packard Co. · Sep 1992
CIBA CORNING MODEL 270 CO-OXIMETER
K913332 · Ciba Corning Diagnostics Corp. · Oct 1991
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