Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Positron · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K926206 | POSICAM-HZ & POSICAM-HZL | Positron | 1993-07-08 | 211 | 0 |
| K911275 | POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM | Positron | 1991-05-09 | 48 | 0 |
| K894998 | MODIFIED POSICAM SYSTEM MODEL 6.5 | Positron | 1989-11-02 | 86 | 0 |
| K810537 | AUTOMATIC SCREENING AUDIOMETER | Positron | 1981-03-11 | 13 | 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