Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Central Solutions, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
33 daysmedian FDA review time
174 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983585 | LOW PH PHENOLIC 256 | Central Solutions, Inc. | 1998-11-06 | 24 | 0 |
| K955850 | PRO-TECH | Central Solutions, Inc. | 1996-02-09 | 44 | 0 |
| K954292 | Q5. 5-5.5NPB-2.5HW | Central Solutions, Inc. | 1995-09-27 | 13 | 0 |
| K951020 | TRI-CEN GERMICIDAL DETERGENT | Central Solutions, Inc. | 1995-08-28 | 174 | 0 |
| K951162 | PHENO-CEN GERMICIDAL DETERGENT | Central Solutions, Inc. | 1995-07-11 | 119 | 0 |
| K951342 | Q4.5-5.0PB-4.5 | Central Solutions, Inc. | 1995-04-25 | 33 | 0 |
| K951317 | PHENO-CEN SPRAY DISINFECTANT DEODORANT | Central Solutions, Inc. | 1995-04-25 | 33 | 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