# K252702: Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N

- Pathway: 510(k) (Traditional)
- Applicant: Bioptimal International Pte., Ltd.
- Decided: May 28, 2026 after 274 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K896466 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160084: Swan Ganz Catheters, Edwards Lifesciences, LLC (2016) Summary page 5.

## Indications for use
Bioptimal Pulmonary Artery Monitoring Catheters are indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Secondary indications are for sampling blood and infusing solutions

Source page: https://510kreport.com/device/K252702
Methodology: https://510kreport.com/methodology