510(k) Report

FDA applicant

Osi Medical, Inc.

Tampa, FL3 decisions2001–20010 recalls

FDA records 3 decisions for Osi Medical, Inc. (Tampa, FL) in 2001: 3 510(k) clearances. All are in product code DQA (Oximeter). Its devices cite 2 predicates, 2 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 Osi Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Osi Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Osi Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DQAOximeter3decisions

Who builds on its devices?

Later devices cite its devices 15 times; 2 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.

  • K002036Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical Sensor, Clip-on…Osi Medical, Inc. · 20017cite it
  • K012533Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and AccessoriesOsi Medical, Inc. · 20014cite it
  • K012626Osi Medical Dolphin Stand-Alone Pulse Oximeter & Digital Dolphin Disposable Optical SendorOsi Medical, Inc. · 20014cite it

What has FDA decided for it lately?

  • K012626Osi Medical Dolphin Stand-Alone Pulse Oximeter & Digital Dolphin Disposable Optical SendorOsi Medical, Inc. · 2001
  • K012533Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and AccessoriesOsi Medical, Inc. · 2001
  • K002036Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical Sensor, Clip-on…Osi Medical, Inc. · 2001

All 3 as Osi Medical, Inc. →