Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cone Instruments, 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) |
|---|---|---|---|---|---|
| K960665 | ECHO-COM FOR MS-WINDOWS VERSION 2.0 | Cone Instruments, Inc. | 1996-05-07 | 77 | 0 |
| K873159 | COMBISON(R) 310A REAL TIME ULTRASOUND SCANNER | Cone Instruments, Inc. | 1988-03-01 | 203 | 0 |
| K861376 | COMBISON R 320A | Cone Instruments, Inc. | 1986-07-03 | 85 | 0 |
| K832501 | ENEMA TUBE | Cone Instruments, Inc. | 1983-08-31 | 35 | 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