Atlas FDA

DQE

19 FDA 510(k) clearances · Product code

71 daysmedian time to decision
194 days90th percentile
19clearances measured

FDA profile

Official device name
Catheter, Oximeter, Fiber-Optic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1230
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 39 · 2022: 57 · 2023: 48 · 2024: 47 · 2025: 31 · 2026: 25
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) (K172423)Edwards Lifescience, LLC2018-02-20
PreSep Oligon Oximetry Catheter (K160645)Edwards Lifesciences, LLC2016-06-16
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER (K140129)Icu Medical, Inc.2014-07-02
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) (K110167)Edwards Lifesciences, LLC2011-02-18
HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS (K091268)Hospira, Inc.2009-09-18
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN (K062999)Hospira, Inc.2006-11-03
OPTICATH CENTRAL VENOUS OXIMETRY CATHETER (K061585)Hospira, Inc.2006-10-05
HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS (K061450)Hospira, Inc.2006-08-04
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN (K061159)Hospira, Inc.2006-06-26
PRESEP OLIGON OXIMETRY CATHETERS (K060093)Edwards Lifesciences, LLC2006-04-28
PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR (K053609)Edwards Lifesciences, LLC2006-02-28
EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH (K926450)Baxter Healthcare Corp1993-02-22
MARQUETTE SV O2 MODULE (K915073)Marquette Electronics, Inc.1992-12-29
SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER (K905458)Baxter Healthcare Corp1991-02-07
OXIMETRY PROBE CATHETERS (K901736)Baxter Healthcare Corp1990-09-11
POET OXIMETER (K864745)Criticare Systems, Inc.1987-06-02
OPTICATH (K820674)Oximetrix, Inc.1982-03-25
CATHETER, THERMAL DILUTION FIBEROPTIC (K781134)Oximetrix, Inc.1978-08-17
OXIMETER, IN VIVO CATHETER (K760234)Oximetrix, Inc.1976-08-23

Track DQE automatically

Every clearance here is in the API, with alerts when new ones post.