Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IXX · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
64 daysmedian FDA review time
274 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963334 | JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE | Jamieson Film Co. | 1996-09-11 | 16 | 0 |
| K915365 | AP-6CR CINERADIOGRAPHIC FILM PROCESSOR | The Allen Products Co. | 1992-08-27 | 274 | 0 |
| K913241 | JAMIESON JT-CRP CINE FILM PROCESSOR | Jamieson Film Co. | 1991-09-24 | 64 | 0 |
| K861928 | STERILE O. R. TOWEL | Anago, Inc. | 1986-06-09 | 20 | 0 |
| K850421 | CINE RADIOGRAPHIC FILM PROCESSOR M-45CR | The Allen Products Co. | 1985-03-22 | 46 | 0 |
| K841431 | RADIOGRAPHIC FILM PROCESSOR M-30CR & | The Allen Products Co. | 1984-07-06 | 91 | 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