# K053609: Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Feb 28, 2006 after 63 days
- Product code: DQE (Catheter, Oximeter, Fiber-Optic)
- Device class: 2
- Regulation: 21 CFR 870.1230
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Central Venous Oximetry Probe Catheter and Probe: named in the summary without a submission number
- (no number) Multi-Med Multi-Lumen Central Venous Catheter: named in the summary without a submission number
- (no number) Edslab Dual Lumen Regional Saturation Oximetry Catheter: named in the summary without a submission number
- (no number) Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor: named in the summary without a submission number
- (no number) SDM Percuglide: named in the summary without a submission number

## Most influential descendants
- K091786: Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable  Probes (PV2022-30 Thru -38, PV2022-46 Thru -48) (2010), 11 descendants of its own
- K132075: Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M) (2014), 10 descendants of its own
- K143195: Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) (2014), 9 descendants of its own
- K152902: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) (2016), 6 descendants of its own
- K170876: Passport Series Patient Monitors (Passport 12m, Passport 17m) (2017), 3 descendants of its own

## Recalls of this device
- Jul 9, 2021 · Class II · Z-2283-2021: There is a potential for internal leaks within catheters.
- Jul 9, 2021 · Class II · Z-2282-2021: There is a potential for internal leaks within catheters.
- Jul 9, 2021 · Class II · Z-2279-2021: There is a potential for internal leaks within catheters.
- Jul 9, 2021 · Class II · Z-2280-2021: There is a potential for internal leaks within catheters.
- Jul 9, 2021 · Class II · Z-2278-2021: There is a potential for internal leaks within catheters.
- Jul 9, 2021 · Class II · Z-2281-2021: There is a potential for internal leaks within catheters.

## Indications for use
The PreSep Oximetry and PediaSat Oximetry Catheters are indicated for hemodynamic monitoring in adults and pediatrics through blood sampling, pressure monitoring and oxygen saturation measurement. The dilator, included with each catheter, is indicated for enlarging the opening in a vessel for preparation of percutaneous entry of the catheter. The Vigileo Arterial Pressure Cardiac Output /Oximetry Monitor is indicated for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics

Source page: https://510kreport.com/device/K053609
Methodology: https://510kreport.com/methodology