Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Litton Medical Systems · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
11 daysmedian FDA review time
13 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K770338 | X-RAY CONTROL & X-RAY HV GENERATOR | Litton Medical Systems | 1977-03-01 | 11 | 0 |
| K770333 | FLUOROSCOPE, C-ARM | Litton Medical Systems | 1977-03-01 | 11 | 0 |
| K770336 | X-RAY TUBE, ROTATING ANODE | Litton Medical Systems | 1977-03-01 | 11 | 0 |
| K770337 | FLUOROSCOPIC ASSEMBLY, IMAGE INTENS. | Litton Medical Systems | 1977-03-01 | 11 | 0 |
| K770334 | TILTING X-RAY TABLE | Litton Medical Systems | 1977-03-01 | 11 | 0 |
| K770335 | COLLIMATOR, AUTOMATIC | Litton Medical Systems | 1977-02-28 | 10 | 0 |
| K760568 | SINGLE PHASE X-RAY CONTROLS & HV GENERATORS | Litton Medical Systems | 1976-09-15 | 13 | 0 |
| K760569 | THREE PHASE X-RAY CONTROLS & HV GENERATORS | Litton Medical Systems | 1976-09-15 | 13 | 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