Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GWZ — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
27 daysmedian FDA review time
94 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K891571 | PERCUSSION HAMMER | Sandal Surgico | 1989-03-31 | 11 | 0 |
| K852716 | TAYLOR PERCUSSION HAMMER SS 410 OR 420 | The Huxley Instrument Corp. | 1985-07-26 | 30 | 0 |
| K851748 | 1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE | Artiberia | 1985-06-13 | 49 | 0 |
| K834178 | H.R. JAKOBI SURG. INSTR. #10 34/36 | Imm Enterprises , Ltd. | 1984-02-23 | 94 | 0 |
| K840314 | CAT 10-NEUROLOGY DEVICE | Imm Enterprises , Ltd. | 1984-02-23 | 30 | 0 |
| K834170 | OP-CON SURG. INSTRUMENT #10 | Imm Enterprises , Ltd. | 1984-02-23 | 94 | 0 |
| K810054 | RICA (DIAGNOSTIC INSTRUMENTS) | Robert I. Chien & Assoc., Inc. | 1981-01-28 | 16 | 0 |
| K803148 | CONPHAR PERCUSSION HAMMER(TAYLOR) | Conphar, Inc. | 1981-01-08 | 27 | 0 |
| K803174 | CONPHAR PERCUSSION HAMMER(BUCK TYPE) | Conphar, Inc. | 1980-12-30 | 15 | 0 |
| K791337 | TAYLOR NEUROLOGICAL HAMMER | Amdia Medical Products | 1979-08-03 | 14 | 0 |
| K791336 | BUCKS NEUROLOGICAL HAMMER | Amdia Medical Products | 1979-08-03 | 14 | 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