Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spectros Corporation — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192322 | T-Stat 2.0 Microvascular Tissue Oximeter | Spectros Corporation | 2019-09-23 | 27 | 0 |
| K081233 | T-STAT 303 ISCHEMIA MONITORING SYSTEM | Spectros Corporation | 2008-07-28 | 88 | 0 |
| K040684 | T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 | Spectros Corporation | 2004-11-05 | 234 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda