Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Frantz Medical Development, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
150 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981541 | CLEARSTAR ENTERAL NUTRITION PUMP | Frantz Medical Development, Ltd. | 1998-08-13 | 106 | 1 |
| K905282 | ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE | Frantz Medical Development, Ltd. | 1991-03-19 | 116 | 0 |
| K873119 | FLEXIFLO COMPANION ENTERAL NUTRITION PUMP | Frantz Medical Development, Ltd. | 1987-11-05 | 87 | 0 |
| K871710 | BIOPSY FORCEPS | Frantz Medical Development, Ltd. | 1987-08-10 | 101 | 0 |
| K863508 | FRANTZ MEDICAL ELECTRODE | Frantz Medical Development, Ltd. | 1987-02-06 | 150 | 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