Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mitek Surgical Products, Inc. — Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
169 daysmedian FDA review time
461 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953560 | MITEK THREADED ANCHOR (FASTIN) | Mitek Surgical Products, Inc. | 1996-01-31 | 195 | 0 |
| K953877 | MITEK GII ANCHOR | Mitek Surgical Products, Inc. | 1995-12-29 | 165 | 0 |
| K936311 | MITEK MINI ANCHOR | Mitek Surgical Products, Inc. | 1995-10-31 | 559 | 0 |
| K941599 | MITEK ABSORBABLE ANCHOR | Mitek Surgical Products, Inc. | 1995-10-24 | 571 | 0 |
| K944051 | ABSORBALBE ANCHOR | Mitek Surgical Products, Inc. | 1995-08-02 | 348 | 0 |
| K950070 | MITEK TOGGLE ANCHOR(TM) | Mitek Surgical Products, Inc. | 1995-05-22 | 133 | 0 |
| K944936 | MITEK G III ANCHOR, MITEK LS ANCHOR | Mitek Surgical Products, Inc. | 1995-03-24 | 169 | 0 |
| K945203 | MITEK THRADED ANCHOR (MTA) | Mitek Surgical Products, Inc. | 1995-03-06 | 132 | 0 |
| K934366 | MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SO | Mitek Surgical Products, Inc. | 1994-10-07 | 395 | 0 |
| K931782 | MITEK GIII ANCHOR | Mitek Surgical Products, Inc. | 1994-07-22 | 469 | 0 |
| K931253 | QUICKANCHOR II | Mitek Surgical Products, Inc. | 1994-06-16 | 461 | 0 |
| K935225 | MITEK MODULAR DRILL BIT | Mitek Surgical Products, Inc. | 1994-04-07 | 157 | 0 |
| K930892 | MITEK MINI ANCHOR, MODIFICATION | Mitek Surgical Products, Inc. | 1994-01-07 | 339 | 0 |
| K930893 | MITEK SUPER QUICKANCHOR, MODIFICATION | Mitek Surgical Products, Inc. | 1993-12-08 | 313 | 0 |
| K930675 | MITEK CONE WASHER | Mitek Surgical Products, Inc. | 1993-11-09 | 273 | 0 |
| K926270 | MITEK LIGAMENT ANCHOR | Mitek Surgical Products, Inc. | 1993-10-22 | 308 | 0 |
| K923161 | BRAIDED POLYESTER SUTURE MATERIAL | Mitek Surgical Products, Inc. | 1992-12-30 | 184 | 0 |
| K924665 | QUICKANCHOR | Mitek Surgical Products, Inc. | 1992-10-27 | 47 | 0 |
| K915889 | MITEK BONE ANCHOR, MODIFICATION | Mitek Surgical Products, Inc. | 1992-10-22 | 307 | 0 |
| K921873 | QUICKANCHOR, MODIFICATION | Mitek Surgical Products, Inc. | 1992-06-09 | 62 | 0 |
| K920213 | MITEK ANCHOR, MITEK ANCHOR II | Mitek Surgical Products, Inc. | 1992-05-01 | 106 | 0 |
| K915089 | MITEK QUICKANCHOR(TM), MODIFICATION | Mitek Surgical Products, Inc. | 1992-02-03 | 83 | 0 |
| K915081 | MITEK SNAP PAK(TM), MODIFICATION | Mitek Surgical Products, Inc. | 1992-01-31 | 80 | 0 |
| K905112 | SNAP-PAK (TM) | Mitek Surgical Products, Inc. | 1991-01-04 | 52 | 0 |
| K904436 | QUICKANCHOR (TM) | Mitek Surgical Products, Inc. | 1990-12-11 | 74 | 0 |
| K902751 | MITEK ANCHOR II | Mitek Surgical Products, Inc. | 1990-07-24 | 32 | 0 |
| K897155 | MITEK ANCHOR(TM) | Mitek Surgical Products, Inc. | 1990-04-04 | 99 | 0 |
| K892903 | MITEK ANCHOR DRILL | Mitek Surgical Products, Inc. | 1989-10-06 | 169 | 0 |
| K892904 | MITEK DRILL GUIDE | Mitek Surgical Products, Inc. | 1989-09-28 | 161 | 0 |
| K892126 | MITEK ANCHOR | Mitek Surgical Products, Inc. | 1989-09-19 | 173 | 0 |
| K893886 | MITEK STERILIZATION TRAY | Mitek Surgical Products, Inc. | 1989-08-21 | 83 | 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