Cleared Traditional

K940933 - 9267 SPO2 ATHENA MODULE

K940933 is the FDA 510(k) clearance for 9267 SPO2 ATHENA MODULE by S & W Medico Teknik. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 639-day FDA review.

K940933 · S & W Medico Teknik · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
639d
Days
Class 2
Risk

K940933 is an FDA 510(k) clearance for the 9267 SPO2 ATHENA MODULE. 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 November 29, 1995 after a review of 639 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all S & W Medico Teknik devices

Submission Details

510(k) Number K940933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1994
Decision Date November 29, 1995
Days to Decision 639 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
499d slower than avg
Panel avg: 140d · This submission: 639d
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 249
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K940933.
VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)
K964978 · Quinton, Inc. · May 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
K970368 · Siemens Medical Solutions USA, Inc. · May 1997
OHMEDA 3800 PULSE OXIMETER
K962127 · Ohmeda Medical · Oct 1996
MARQUETTE ADULT/NEONATAL WRAP SENSOR
K943817 · Marquette Electronics, Inc. · Oct 1994
HP M1722A/B AND M1723A/B CODEMASTER
K944608 · Hewlett-Packard Co. · Oct 1994
OHMEDA HAND HELD OXIMETER
K931304 · Ohmeda Medical · Sep 1994