Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tingle X-Ray Products, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K926554 | 525 SFQ X-RAY CONTROL W/HIGH VOLTAGE GENERATOR | Tingle X-Ray Products, Inc. | 1993-05-17 | 137 | 0 |
| K930249 | BC/WT/PF | Tingle X-Ray Products, Inc. | 1993-04-27 | 98 | 0 |
| K860203 | TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR | Tingle X-Ray Products, Inc. | 1986-01-30 | 8 | 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