Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Electro-Biology, Inc. — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
194 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992333 | EBI OMEGA 21 SYSTEM | Electro-Biology, Inc. | 1999-10-08 | 87 | 0 |
| K992367 | EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS | Electro-Biology, Inc. | 1999-09-23 | 70 | 1 |
| K991941 | EBI XFIX DFS RAIL SYSTEM | Electro-Biology, Inc. | 1999-08-19 | 71 | 0 |
| K991092 | EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM | Electro-Biology, Inc. | 1999-04-29 | 28 | 0 |
| K990303 | EBI OMEGA 21 SYSTEM | Electro-Biology, Inc. | 1999-04-29 | 87 | 0 |
| K990459 | EBI VUECATH ENDOSCOPIC SYSTEN | Electro-Biology, Inc. | 1999-04-23 | 70 | 0 |
| K990999 | MODIFICATION OF: EBI SPINELINK SYSTEM | Electro-Biology, Inc. | 1999-04-14 | 20 | 0 |
| K984027 | EBI SPINELINK SYSTEM | Electro-Biology, Inc. | 1999-01-19 | 68 | 0 |
| K982484 | EBI VUECATH ENDOSCOPIC SPINAL SYSTEM | Electro-Biology, Inc. | 1998-10-08 | 83 | 1 |
| K982908 | MODIFICATION TO EBI SPINELINK SYSTEM | Electro-Biology, Inc. | 1998-08-28 | 10 | 0 |
| K981483 | EBI DFS JOINT FIXATOR, MODEL 02800 | Electro-Biology, Inc. | 1998-07-08 | 75 | 0 |
| K971970 | EBI SPINELINK SYSTEM | Electro-Biology, Inc. | 1997-08-20 | 83 | 0 |
| K971083 | ARTHROSCOPE | Electro-Biology, Inc. | 1997-06-23 | 90 | 1 |
| K964797 | EBI SPINELINK SYSTEM | Electro-Biology, Inc. | 1997-05-02 | 154 | 0 |
| K964533 | EBI SPINELINK SYSTEM | Electro-Biology, Inc. | 1997-04-09 | 148 | 0 |
| K963261 | EBI THERMAL THERAPY SYSTEM | Electro-Biology, Inc. | 1996-09-27 | 38 | 0 |
| K961433 | EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BO | Electro-Biology, Inc. | 1996-06-28 | 74 | 0 |
| K955730 | EBI ANTERIOR CERVICAL SPINE SYSTEM | Electro-Biology, Inc. | 1996-03-13 | 86 | 0 |
| K953406 | EBI X FIX DYNAFIX SYSTEM (DFS) | Electro-Biology, Inc. | 1995-10-31 | 103 | 0 |
| K953532 | EBICE | Electro-Biology, Inc. | 1995-10-04 | 69 | 0 |
| K945781 | WEBB-MORLEY SPINE SYSTEM | Electro-Biology, Inc. | 1995-06-22 | 209 | 0 |
| K951357 | EBI SMALL EXTERNAL FIXATOR (S/E/F/) | Electro-Biology, Inc. | 1995-06-21 | 89 | 0 |
| K945067 | EBICE | Electro-Biology, Inc. | 1995-02-09 | 118 | 0 |
| K943694 | EBI ANTERIOR CERVICAL SPINE SYSTEM | Electro-Biology, Inc. | 1995-02-08 | 194 | 0 |
| K941367 | WEBB-MORLEY SPINE SYSTEM | Electro-Biology, Inc. | 1994-12-05 | 259 | 0 |
| K860632 | EBI HAND MASSAGING PUMP (HMP) | Electro-Biology, Inc. | 1986-04-18 | 57 | 0 |
| K852264 | EBI FOOT MASSAGING PUMP | Electro-Biology, Inc. | 1985-07-19 | 56 | 0 |
| K831576 | ORTHOFIX | Electro-Biology, Inc. | 1983-06-08 | 23 | 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