Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Terumobct, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
177 daysmedian FDA review time
249 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183081 | Spectra Optia Apheresis System | Terumobct, Inc. | 2019-02-05 | 91 | 0 |
| K181049 | Spectra Optia Apheresis System | Terumobct, Inc. | 2018-11-01 | 195 | 0 |
| K172590 | Spectra Optia Apheresis System | Terumobct, Inc. | 2018-03-02 | 185 | 0 |
| K162365 | T-Cuff | Terumobct, Inc. | 2017-02-16 | 177 | 0 |
| K153601 | Spectra Optia Apheresis System | Terumobct, Inc. | 2016-01-14 | 29 | 0 |
| K141938 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET ( | Terumobct, Inc. | 2015-03-23 | 249 | 0 |
| K132429 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWAR | Terumobct, Inc. | 2013-12-06 | 123 | 0 |
| K131744 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE | Terumobct, Inc. | 2013-08-08 | 56 | 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