Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stellate Systems — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
999 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083577 | HARMONIE SYSTEM | Stellate Systems | 2011-08-29 | 999 | 1 |
| K013450 | NOTTA AMBULATORY RECORDER | Stellate Systems | 2002-01-14 | 89 | 0 |
| K010728 | HARMONE-SCHWARZER EEG SYSTEM | Stellate Systems | 2001-05-21 | 70 | 1 |
| K982351 | LUNA | Stellate Systems | 1998-07-29 | 23 | 0 |
| K955577 | ECLIPSE VERSION 3.0 | Stellate Systems | 1996-09-20 | 317 | 0 |
| K960273 | HARMONIE SENSA | Stellate Systems | 1996-04-04 | 76 | 0 |
| K912938 | RHYTHM | Stellate Systems | 1991-07-30 | 25 | 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