510(k) Report

FDA applicant

Spectra Science

San Diego2 decisions2000–20061 recall

FDA records 2 decisions for Spectra Science (San Diego) from 2000 to 2006: 2 original PMA approvals. Most are in product codes MOA (Analyzer, Diagnostic, Fiber Optic (Colon)) and MWM (Sensor, Electro-Optical (For Cervical Cancer)). 1 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Spectra Science since 2007.

Recalls per year

1in 2007

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

Class I Class II/III not classified

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

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Other applicant names beginning “Spectra”

FDA records each applicant name separately; these may or may not be the same firm.