510(k) Report

FDA applicant

Sunscope Intl., Inc.

Newport Beach, CA7 decisions1991–20000 recalls

FDA records 7 decisions for Sunscope Intl., Inc. (Newport Beach, CA) from 1991 to 2000: 7 510(k) clearances. Most are in product codes DRS (Transducer, Blood-Pressure, Extravascular) and DQO (Catheter, Intravascular, Diagnostic). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Sunscope Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sunscope Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sunscope Intl., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DRSTransducer, Blood-Pressure, Extravascular3decisions
  • DQOCatheter, Intravascular, Diagnostic1decision
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision
  • DXECatheter, Embolectomy1decision
  • KRBProbe, Thermodilution1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K981747Biotrans Pressure Monitoring Kit Model Number BT XxxxxxSunscope Intl., Inc. · 19981cites it
  • K911710Heparin Coated Thermodilution Cath & AccessoriesSunscope Intl., Inc. · 19911cites it
  • K973477Biosensors Embolectomy CatheterSunscope Intl., Inc. · 19981cites it

What has FDA decided for it lately?

  • K002786Biosensors Central Venous Catheter KitsSunscope Intl., Inc. · 2000
  • K983372Bioport Closed Blood Sampling System, Model BT Xxxxxx- BPSunscope Intl., Inc. · 1999
  • K973477Biosensors Embolectomy CatheterSunscope Intl., Inc. · 1998
  • K981747Biotrans Pressure Monitoring Kit Model Number BT XxxxxxSunscope Intl., Inc. · 1998
  • K981745Biotrans Reusable Sensor Base Model Number BT XxxxxxSunscope Intl., Inc. · 1998
  • K911710Heparin Coated Thermodilution Cath & AccessoriesSunscope Intl., Inc. · 1991
  • K912172Safewedge (TM) Relief Valve DeviceSunscope Intl., Inc. · 1991

All 7 as Sunscope Intl., Inc. →