510(k) Report

FDA applicant

Spectros Corporation

Portola Valley, CA3 decisions2004–20190 recalls

FDA records 3 decisions for Spectros Corporation (Portola Valley, CA) from 2004 to 2019: 3 510(k) clearances. All are in product code MUD (Oximeter, Tissue Saturation). Its devices cite 8 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 Spectros Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2008: 12019: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Spectros Corporation 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?

  • MUDOximeter, Tissue Saturation3decisions

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 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.

  • K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 20047cite it
  • K081233T-Stat 303 Ischemia Monitoring SystemSpectros Corporation · 20083cite it

What has FDA decided for it lately?

  • K192322T-Stat 2.0 Microvascular Tissue OximeterSpectros Corporation · 2019
  • K081233T-Stat 303 Ischemia Monitoring SystemSpectros Corporation · 2008
  • K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004

All 3 as Spectros Corporation →