Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spectra Medical Devices · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163292 | Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, S | Spectra Medical Devices | 2017-09-08 | 290 | 0 |
| K142791 | Spectra Soft Tissue Biopsy Needles | Spectra Medical Devices | 2015-01-21 | 117 | 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