Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Johannah Medical Services, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K801304 | CAMLOC SYRINGE BIOPSY KIT | Johannah Medical Services, Inc. | 1980-06-17 | 9 | 0 |
| K791643 | BONE MARROW NEEDLE | Johannah Medical Services, Inc. | 1979-09-12 | 20 | 0 |
| K771108 | NEEDLE, CHIBA UNIVERSITY | Johannah Medical Services, Inc. | 1977-07-29 | 39 | 0 |
| K770370 | CONVENIENCE TRAY | Johannah Medical Services, Inc. | 1977-03-16 | 20 | 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