Cleared Traditional

K911124 - 503 PULSE OXIMETER

K911124 is an FDA 510(k) clearance for 503 PULSE OXIMETER, manufactured by Criticare Systems, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K911124 · Criticare Systems, Inc. · Anesthesiology device
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Jun 1991
Decision
87d
Days
Class 2
Risk

K911124 is an FDA 510(k) clearance for the 503 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 June 7, 1991 after a review of 87 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

FDA 510(k) Submission Details - K911124

510(k) Number K911124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1991
Decision Date June 07, 1991
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

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 457
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K911124.
SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION
K911761 · S & W Medico Teknik · Oct 1991
CIBA CORNING MODEL 270 CO-OXIMETER
K913332 · Ciba Corning Diagnostics Corp. · Oct 1991
MODEL 8604-FO PULSE OXIMETER
K910001 · Nonin Medical, Inc. · Jul 1991
SATLITE PLUS PULSE OXIMETER
K905140 · Datex Division Instrumentarium Corp. · May 1991
AP-860PA NIBP MODULE
K910629 · Nihon Kohden America, Inc. · May 1991
504US PULSE OXIMETER
K910770 · Criticare Systems, Inc. · May 1991