DQA · Class II · 21 CFR 870.2700

FDA Product Code DQA: Oximeter

Continuous oxygen saturation monitoring is a cornerstone of safe patient care across clinical settings. FDA product code DQA covers pulse oximeters and oximeter systems.

These devices use near-infrared light to non-invasively measure the oxygen saturation of hemoglobin in arterial blood, providing a continuous, real-time assessment of respiratory status. They are standard equipment in operating rooms, intensive care units, and emergency departments worldwide.

DQA devices are Class II medical devices, regulated under 21 CFR 870.2700 and reviewed by the FDA Anesthesiology panel.

Leading manufacturers include Masimo Corporation, Nonin Medical, Inc. and Masimo Corp..

727
Total
727
Cleared
162d
Avg days
1978
Since
727 devices
457–480 of 727
Cleared Nov 02, 2001
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR
K012626
Osi Medical, Inc.
Anesthesiology · 81d
Cleared Oct 26, 2001
VITALSAT PULSE OXIMETER, MODEL IC32000
K011365
Island Critical Care Corp.
Anesthesiology · 175d
Cleared Oct 03, 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES
K012992
Masimo Corp.
Anesthesiology · 27d
Cleared Aug 22, 2001
MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES
K012533
Osi Medical, Inc.
Anesthesiology · 16d
Cleared Aug 09, 2001
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
K011320
Hitachi Medical Systems America, Inc.
Anesthesiology · 100d
Cleared Aug 02, 2001
MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
K010413
Konica Minolta Sensing, Inc.
Anesthesiology · 171d
Cleared Jul 11, 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K011851
Masimo Corp.
Anesthesiology · 28d
Cleared Jun 26, 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE
K011670
Datex-Ohmeda
Anesthesiology · 27d
Cleared Jun 14, 2001
BCI 3403 SLEEP SCREENING PULSE OXIMETER
K011156
Bci, Inc.
Anesthesiology · 59d
Cleared Jun 08, 2001
MEDLEY SP02 MODULE, MODEL 8220
K010966
Alaris Medical Systems, Inc.
Anesthesiology · 67d
Cleared May 24, 2001
SPO2 WRAP SENSOR
K002848
Epic Medical Equipment Services, Inc.
Anesthesiology · 253d
Cleared Apr 25, 2001
NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
K010451
Novametrix Medical Systems, Inc.
Anesthesiology · 69d
Cleared Apr 17, 2001
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD
K002036
Osi Medical, Inc.
Anesthesiology · 286d
Cleared Apr 06, 2001
PREAMP CABLE, MODEL B400-1011PA
K003542
Beta Biomed Services, Inc.
Anesthesiology · 140d
Cleared Mar 29, 2001
FINGER PULSE METER
K000814
Bhs Intl., Inc.
Anesthesiology · 381d
Cleared Mar 15, 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
K010463
Datex-Ohmeda, Inc.
Anesthesiology · 27d
Cleared Mar 06, 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K010419
Masimo Corp.
Anesthesiology · 22d
Cleared Mar 02, 2001
HOMMED SENTRY III PATIENT MONITOR SYSTEM
K004044
Hommed, LLC
Anesthesiology · 63d
Cleared Mar 01, 2001
PROFOX SOFTWARE, MODEL 920M-41
K001708
Respironics Georgia, Inc.
Anesthesiology · 269d
Cleared Nov 29, 2000
MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120
K002787
Palco Labs, Inc.
Anesthesiology · 83d
Cleared Nov 08, 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K003167
Masimo Corp.
Anesthesiology · 29d
Cleared Nov 08, 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K003244
Masimo Corp.
Anesthesiology · 22d
Cleared Oct 18, 2000
SOLAR SPO2 MODULE WITH MASIMO SET
K002957
General Electric Medical Systems Information Techn
Anesthesiology · 26d
Cleared Oct 11, 2000
MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500
K002690
Nonin Medical, Inc.
Anesthesiology · 43d