510(k) Report

510(k) · Cleared

Cleared

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

K252702510(k) TraditionalCleared May 28, 2026274-day reviewClass II21 CFR 870.1200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bioptimal International Pte., Ltd. · DQO Catheter, Intravascular, Diagnostic

Cleared on May 28, 2026 as substantially equivalent to K160084 (Edwards Lifesciences, LLC, 2016) after a 274-day review. Its family tree reaches back 3 generations to 1990. 1 of the 13 devices in its family, counting itself, has a Class I recall.

Decided
May 28, 2026
Review
274 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K896466 (1990). 12 ancestors in all, the oldest K810124 (1981). No later device cites it as a predicate yet. 1 of the 13 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2000: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor1991: 2 other ancestors1989: 1 other ancestor1982: 1 other ancestor1981: 2 other ancestorsK896466 · Swan-Ganz Thermodilution Ejection Fraction/Volume · Baxter Healthcare Corp · 1990K951566 · Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection Fraction/Volumetric (Cco/SVO2/Vip/Ref) Cath] · Baxter Healthcare Corp · 1995K160084 · Swan Ganz Catheters · Edwards Lifesciences, LLC · 2016 · Class I recall19801990200020102020
Other ancestors, by generation 2 generations back: 9 other ancestors K160084 · Swan Ganz Catheters · Edwards Lifesciences, LLC · 2016 · Class I recallK951566 · Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection Fraction/Volumetric (Cco/SVO2/Vip/Ref) Cath] · Baxter Healthcare Corp · 1995K896466 · Swan-Ganz Thermodilution Ejection Fraction/Volume · Baxter Healthcare Corp · 19900
  1. Root · 3 generations backK896466 Swan-Ganz Thermodilution Ejection Fraction/VolumeBaxter Healthcare Corp · 1990
  2. 2 generations backK951566 Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion…Baxter Healthcare Corp · 1995
  3. 1 generation backK160084 Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · Recalled (Class I)
  4. This deviceK252702 Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF…Bioptimal International Pte., Ltd. · 2026

Class I recalls in this family

  • K160084 Swan Ganz Cathetersdirect predicate · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K896466Swan-Ganz Thermodilution Ejection Fraction/VolumeBaxter Healthcare Corp1990—
−2K951566Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection…Baxter Healthcare Corp1995—
−1K160084Swan Ganz CathetersEdwards Lifesciences, LLC2016Class I
0 (this device)K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF…Bioptimal International Pte., Ltd.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198120
198210
198910
199120
199310
199410
200010
FIG. 1 — Lineage of K252702, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K160084Swan Ganz Catheters
Summary page 5
…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K160084 Swan-Ganz Flow-Directed Monitoring Catheter DQO Device Descri…
Edwards Lifesciences, LLC2016Class I

Also cleared against K160084: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K160084Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls

What does this lineage say?

  • The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
  • 4 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
  • 5 other devices also cite its predicate K160084.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—

What is it indicated for?

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

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K160084

5 other devices cite the same predicate.

  • K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024
  • K233824Swan-Ganz catheterEdwards Lifesciences, LLC · 20241 recall
  • K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLC · 20232 recalls
  • K222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLC · 2022
  • K193466Swan-Ganz CathetersEdwards Lifesciences, LLC · 2020

More from Bioptimal International Pte., Ltd.

2 FDA decisions under this applicant name. See the company

  • K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte., Ltd. · 2025

Recent decisions in DQO

The DQO category page

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250751DualView CatheterTerumo Corporation · 2025
  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall
  • K242420pNOVUS 21 MicrocatheterPhenox, Ltd. · 2024

https://510kreport.com/device/K252702 · printed Nov 6, 2026

Cite this page

510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252702

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026