# K172423: PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifescience, LLC
- Decided: Feb 20, 2018 after 194 days
- Product code: DQE (Catheter, Oximeter, Fiber-Optic)
- Device class: 2
- Regulation: 21 CFR 870.1230
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001901 (2000). 27 ancestors in all.
No later device cites it as a predicate yet.
4 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053609: Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Edwards Lifesciences, LLC (2006) Summary page 4.
- K160645: PreSep Oligon Oximetry Catheter, Edwards Lifesciences, LLC (2016) Summary page 4.

## Recalls of this device
- Mar 27, 2020 · Class II · Z-2007-2020: Sterile catheter kit packaging compromised.

## Indications for use
The EOCVC Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements, PediaSat Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements in adults and/or pediatric patients. The pressure injectable EOCVC Oligon catheters are indicated for short term (< 30 days) hemodynamic monitoring through blood sampling, infusion of solutions, continuous monitoring of oxygen saturation measurements, pressure injection of contrast media, and central venous pressure monitoring, The suture loop and box clamp are intended to be used to facilitate the suturing the catheter at the site of insertion. The dilator, included with each catheter, is indicated for enlarging the opening in a vessel for preparation of percutaneous entry of the catheter.

Source page: https://510kreport.com/device/K172423
Methodology: https://510kreport.com/methodology