Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Perception, Inc. · 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) |
|---|---|---|---|---|---|
| K981834 | PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM | Perception, Inc. | 1998-09-29 | 126 | 0 |
| K974880 | PERCEPTION GPS-RST DIAGNOSTIC ULTRASOUND SYSTEM | Perception, Inc. | 1998-06-08 | 160 | 0 |
| K972192 | PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM | Perception, Inc. | 1997-12-17 | 190 | 0 |
| K972973 | PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM | Perception, Inc. | 1997-10-15 | 65 | 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