Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JFA — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
29 daysmedian FDA review time
289 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945803 | THERMAFLEX, MODEL SD 55 C.P.M.H. | Burke Neutech, Inc. | 1995-05-11 | 164 | 0 |
| K931016 | JACE MODEL H440 HAND CPM DEVICE | Jace Systems, Inc. | 1994-06-22 | 481 | 0 |
| K933418 | HAND THERAPY ASSOST | Bardon Ent., Inc. | 1994-04-28 | 289 | 0 |
| K921351 | JACE MODEL PM-410 HAND CPM DEVICE | Jace Systems, Inc. | 1992-05-04 | 46 | 0 |
| K900794 | MOBILIMB H3 HAND CPM UNIT | Toronto Medical Corp. | 1990-03-02 | 10 | 0 |
| K900581 | DANNIFLEX CPM 880(TM) | Buckman Co., Inc. | 1990-02-20 | 13 | 0 |
| K880686 | TORONTO/MOBILIMB HAND C.P.M. | Toronto Medical Corp. | 1988-02-26 | 7 | 0 |
| K880336 | MOBILIMB HAND C.P.M. UNIT | Toronto Medical Corp. | 1988-02-16 | 21 | 0 |
| K860714 | ACE AIM - CPM HAND UNIT | Buckman Co., Inc. | 1986-03-27 | 29 | 0 |
| K844033 | MOBILIMB HAND UNIT | Danninger Medical Technology, Inc. | 1984-11-27 | 43 | 0 |
| K830974 | SUTTER CPM 5000 | Sutter Biomedical, Inc. | 1983-04-12 | 15 | 0 |
| K790527 | BURNETT-KETCHUM DYNAMIC HAND EXERCISER | Maddak, Inc. | 1979-03-22 | 7 | 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