Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dfine, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
143 daysmedian FDA review time
464 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091310 | ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER | Dfine, Inc. | 2010-08-11 | 464 | 0 |
| K090986 | STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGME | Dfine, Inc. | 2009-12-30 | 267 | 0 |
| K072496 | MODIFICATION TO SPACE CPSXL BONE CEMENT | Dfine, Inc. | 2007-10-05 | 30 | 0 |
| K070351 | SPACE 360 DELIVERY SYSTEM | Dfine, Inc. | 2007-06-29 | 143 | 0 |
| K061531 | SPACE CPSXL BONE CEMENT | Dfine, Inc. | 2006-08-30 | 89 | 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