Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hall Surgical, Division of Zimmer, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
93 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942660 | HALL MICROCHOICE ELECTRIC POWERED SYSTEM | Hall Surgical, Division of Zimmer, Inc. | 1994-09-07 | 93 | 1 |
| K864734 | HALL ORAL IMPLANT SYSTEM | Hall Surgical, Division of Zimmer, Inc. | 1987-02-10 | 68 | 0 |
| K864929 | HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST | Hall Surgical, Division of Zimmer, Inc. | 1987-01-28 | 43 | 0 |
| K864163 | HALL DUNBAR DRILL GUIDE SYSTEM | Hall Surgical, Division of Zimmer, Inc. | 1986-11-20 | 28 | 0 |
| K862778 | HALL CANNLULA SYSTEM | Hall Surgical, Division of Zimmer, Inc. | 1986-09-08 | 48 | 0 |
| K862474 | HALL STERNUM SAW | Hall Surgical, Division of Zimmer, Inc. | 1986-07-17 | 17 | 0 |
| K862529 | HALL STERILE BUR | Hall Surgical, Division of Zimmer, Inc. | 1986-07-15 | 13 | 0 |
| K852143 | HALL IRRIGATION SYSTEM | Hall Surgical, Division of Zimmer, Inc. | 1985-06-26 | 41 | 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