510(k) Report

FDA applicant

Solaris Medical Technology, Inc.

South San Francisco, CA5 decisions2007–20100 recalls

FDA records 5 decisions for Solaris Medical Technology, Inc. (South San Francisco, CA) from 2007 to 2010: 5 510(k) clearances. Most are in product codes DQA (Oximeter) and DXQ (Blood Pressure Cuff). Its devices cite 10 predicates, 1 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 Solaris Medical Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2010

2007: 12008: 12010: 3
2007high 3 (2010) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Solaris Medical Technology, 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?

  • DQAOximeter4decisions
  • DXQBlood Pressure Cuff1decision

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc. · 20104cite it
  • K073249Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor AccessoriesSolaris Medical Technology, Inc. · 20082cite it

What has FDA decided for it lately?

  • K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc. · 2010
  • K101972Solaris Reusable and Disposable Blood Pressure CuffsSolaris Medical Technology, Inc. · 2010
  • K092950Solaris Models NT1 and NT1A Handheld Pulse Oximeters with Sensor AccessoriesSolaris Medical Technology, Inc. · 2010
  • K073249Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor AccessoriesSolaris Medical Technology, Inc. · 2008
  • K061931Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103, S200A-090101 and 300101Solaris Medical Technology, Inc. · 2007

All 5 as Solaris Medical Technology, Inc. →