Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HTZ — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
36 daysmedian FDA review time
93 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933933 | CEBOPLANE | Synvasive Technology, Inc. | 1994-04-15 | 247 | 0 |
| K931737 | HEDLEYL INTRAMEDULLARY PREPARATION BRUSH | Synvasive Technology, Inc. | 1994-01-07 | 275 | 0 |
| K870882 | 45 DEGREE SHAVER | Bowen & Company, Inc. | 1987-03-23 | 18 | 0 |
| K853678 | KAMBIN SPINAL INSTRUMENT SET | Pilling Co. | 1985-09-24 | 21 | 0 |
| K850423 | CONCEPT SUCTION SLEEVE | Concept, Inc. | 1985-03-14 | 38 | 0 |
| K850527 | ARTHROSCOPY SUCTION BIOPSY PUNCH | T. Korossurgical Instruments Corp. | 1985-03-14 | 35 | 0 |
| K841980 | SIDE CUTTING SERRATED BLADE | Stainless Mfg., Inc. | 1984-08-15 | 93 | 0 |
| K842774 | CODMAN SUCTION PUNCH-PRODUCT CODES | Codman & Shurtleff, Inc. | 1984-07-27 | 11 | 0 |
| K841975 | ROSETTE KNIFE 4MM | Stainless Mfg., Inc. | 1984-06-19 | 36 | 0 |
| K841978 | LATERAL RELEASE KNIFE 5MM & 7MM | Stainless Mfg., Inc. | 1984-06-19 | 36 | 0 |
| K842111 | KOGAN ENDOSPECULUM 9-1/2 | J. Sklar Mfg. Co., Inc. | 1984-06-19 | 21 | 0 |
| K841982 | MENISCOTOME 4MM & 5MM | Stainless Mfg., Inc. | 1984-06-19 | 36 | 0 |
| K841976 | HOOK KNIFE 4MM & 5MM | Stainless Mfg., Inc. | 1984-06-19 | 36 | 0 |
| K841974 | RETROGRADE KNIFE 4MM & 5MM | Stainless Mfg., Inc. | 1984-06-19 | 36 | 0 |
| K841972 | BANANA KNIFE - K841969-LABELING | Stainless Mfg., Inc. | 1984-06-19 | 36 | 0 |
| K841977 | 5MM DOUGLE EDGE RING CURETTE | Stainless Mfg., Inc. | 1984-06-19 | 36 | 0 |
| K841973 | BANANA KNIFE SERRATED | Stainless Mfg., Inc. | 1984-06-19 | 36 | 0 |
| K831772 | GUILLOTINE BLADE | Ortho Pared Instruments, Inc. | 1983-07-07 | 35 | 0 |
| K771915 | MICRO OSCILLATING SAW | American Sterilizer Co. | 1977-10-21 | 9 | 0 |
| K771005 | NEW PODIATRY PRODUCTS | Dentronix, Inc. | 1977-06-17 | 15 | 0 |
| K771006 | MODIFIED PODIATRY PRODUCTS | Dentronix, Inc. | 1977-06-17 | 15 | 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