Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bay X-Ray, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
87 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883161 | HIMOBILIX 2N | Bay X-Ray, Inc. | 1988-10-21 | 87 | 0 |
| K883160 | CATAPULT BUCKY (KATAPULT BLENDA) | Bay X-Ray, Inc. | 1988-09-08 | 44 | 0 |
| K883162 | TELESTATIX X-RAY TABLE | Bay X-Ray, Inc. | 1988-09-06 | 42 | 0 |
| K883154 | SELDIX 325 TWO PULSE GENERATOR/CONTROL | Bay X-Ray, Inc. | 1988-09-06 | 42 | 0 |
| K883155 | RASTIX X-RAY TABLE | Bay X-Ray, Inc. | 1988-09-06 | 42 | 0 |
| K883153 | UNDISTAT WITH EXPLORATOR 35 (UCS 35E) | Bay X-Ray, Inc. | 1988-09-06 | 42 | 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