Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Block Medical, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
221 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944692 | C-SERIES HOMEPUMP | Block Medical, Inc. | 1995-05-02 | 221 | 0 |
| K940117 | MID-500 | Block Medical, Inc. | 1994-06-10 | 151 | 0 |
| K934551 | VERIFUSE AMBULATORY PUMP | Block Medical, Inc. | 1994-03-17 | 176 | 0 |
| K935236 | FLOW CONTROLLING EXTENSION SET | Block Medical, Inc. | 1994-02-24 | 115 | 0 |
| K932740 | HOMEPUMP NSF | Block Medical, Inc. | 1993-10-06 | 120 | 5 |
| K904663 | AUTO SASH (TM) | Block Medical, Inc. | 1992-11-23 | 773 | 0 |
| K914924 | CHEMO PRIMING PIN(TM) | Block Medical, Inc. | 1992-03-06 | 123 | 0 |
| K914855 | MULTIPLE DOSE CONTROLLER | Block Medical, Inc. | 1992-01-24 | 88 | 0 |
| K914854 | THUMPER | Block Medical, Inc. | 1992-01-24 | 88 | 0 |
| K910695 | AUTO SASH (TM) | Block Medical, Inc. | 1991-03-21 | 30 | 0 |
| K902891 | VERIFUSE AMBULATORY PUMP | Block Medical, Inc. | 1990-11-21 | 142 | 0 |
| K896546 | HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE) | Block Medical, Inc. | 1990-02-06 | 81 | 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