Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Control-X, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
157 daysmedian FDA review time
479 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952265 | MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/5 | Control-X, Inc. | 1995-07-06 | 52 | 0 |
| K920347 | TOP-X 650HF RADIOGRAPHIC X-RAY | Control-X, Inc. | 1993-05-17 | 479 | 0 |
| K924445 | BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY | Control-X, Inc. | 1993-02-19 | 171 | 0 |
| K920349 | PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR | Control-X, Inc. | 1993-02-12 | 385 | 0 |
| K920351 | PCX 650HF RADIOGRAPHIC X-RAY | Control-X, Inc. | 1993-02-12 | 385 | 0 |
| K924443 | RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE | Control-X, Inc. | 1993-02-05 | 157 | 0 |
| K924444 | B-4 FOUR-WAY RADIOGRAPHIC TABLE | Control-X, Inc. | 1993-02-05 | 157 | 0 |
| K913577 | MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR | Control-X, Inc. | 1991-11-05 | 85 | 0 |
| K913578 | MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR | Control-X, Inc. | 1991-11-01 | 81 | 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