Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Computed Anatomy, 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) |
|---|---|---|---|---|---|
| K944207 | TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 | Computed Anatomy, Inc. | 1994-12-07 | 100 | 0 |
| K902012 | VKS-1 VIDEO KERATOSCOPE | Computed Anatomy, Inc. | 1990-06-22 | 50 | 0 |
| K901363 | TOPOGRAPHIC MODELING SYSTEM | Computed Anatomy, Inc. | 1990-05-25 | 63 | 0 |
| K862379 | CORNEAL MODELING SYSTEM | Computed Anatomy, Inc. | 1986-08-25 | 62 | 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