Cleared Traditional

K884121 - TYPE 9266 SAO2 SYSTEM ATHENA

K884121 is an FDA 510(k) clearance for TYPE 9266 SAO2 SYSTEM ATHENA, manufactured by S & W Medico Teknik. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K884121 · S & W Medico Teknik · Anesthesiology device
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Apr 1989
Decision
207d
Days
Class 2
Risk

K884121 is an FDA 510(k) clearance for the TYPE 9266 SAO2 SYSTEM ATHENA. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on April 25, 1989 after a review of 207 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all S & W Medico Teknik devices

FDA 510(k) Submission Details - K884121

510(k) Number K884121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1988
Decision Date April 25, 1989
Days to Decision 207 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
67d slower than avg
Panel avg: 140d · This submission: 207d
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 502
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K884121.
MINIMON 7137B PATIENT MONITOR
K895425 · Kontron Instruments, Inc. · Sep 1989
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K893867 · Spacelabs, Inc. · Sep 1989
OXIMETER
K893587 · Radiometer America, Inc. · Sep 1989
SATLITE TRANS PORTABLE PULSE OXIMETER
K890753 · Datex Division Instrumentarium Corp. · Mar 1989
KONTRON PULSE OXIMETER 7840
K890299 · Kontron Instruments, Inc. · Mar 1989
CNS-8200A CENTRAL NURSES STATION
K884050 · Nihon Kohden America, Inc. · Feb 1989