510(k) Report

FDA applicant

Spectrx, Inc.

North Attleboro, MA2 decisions2000–20050 recalls

FDA records 2 decisions for Spectrx, Inc. (North Attleboro, MA) from 2000 to 2005: 2 510(k) clearances. Most are in product codes MQM (Bilirubin (Total And Unbound) In The Neonate…) and FRN (Pump, Infusion). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Spectrx, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Spectrx, 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?

  • MQMBilirubin (Total And Unbound) In The Neonate Test System1decision
  • FRNPump, Infusion1decision

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 1 time; 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.

  • K051045Simplechoice 3.0 ML Reservoir Pro Reference Number RP-30Spectrx, Inc. · 20051cites it

What has FDA decided for it lately?

  • K051045Simplechoice 3.0 ML Reservoir Pro Reference Number RP-30Spectrx, Inc. · 2005
  • K994438Bilichek Non-Invasive Bilirubin AnalyzerSpectrx, Inc. · 2000

All 2 as Spectrx, Inc. →