Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Frantz Imaging, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
33 daysmedian FDA review time
329 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952485 | LASERNET IMAGE MANAGER/PRINT SERVER | Frantz Imaging, Inc. | 1995-11-24 | 178 | 0 |
| K921215 | LASERSTAR IMAGER | Frantz Imaging, Inc. | 1993-02-05 | 329 | 0 |
| K871957 | SPACEMISER 8-10 FILM RECORDER | Frantz Imaging, Inc. | 1987-06-22 | 33 | 0 |
| K871958 | SPACEMISER 8-17 FILM RECORDER | Frantz Imaging, Inc. | 1987-06-22 | 33 | 0 |
| K871959 | FRANTZ IMAGING COMPACT CAMERA | Frantz Imaging, Inc. | 1987-06-22 | 33 | 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