Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rhytec Incorporated — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
24 daysmedian FDA review time
152 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082197 | RHYTEC, INC., PORTRAIT PSR | Rhytec Incorporated | 2008-08-22 | 18 | 0 |
| K073111 | PORTRAIT PSR, MODEL 745915 | Rhytec Incorporated | 2008-03-27 | 143 | 0 |
| K072394 | PORTRAIT STAND-OFF | Rhytec Incorporated | 2007-09-12 | 16 | 0 |
| K071786 | PORTRAIT PSR | Rhytec Incorporated | 2007-07-26 | 24 | 0 |
| K060948 | PORTRAIT PSR3 | Rhytec Incorporated | 2006-09-05 | 152 | 1 |
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