Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mitek Products — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
203 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013572 | MITEK BIOCRYL INTERFERENCE SCREWS | Mitek Products | 2002-03-14 | 136 | 0 |
| K013781 | RIDIDFIX 2.7MM BTB CROSS PIN KIT | Mitek Products | 2002-02-06 | 84 | 0 |
| K002639 | BIOKNOTLESS ANCHOR | Mitek Products | 2001-05-11 | 260 | 2 |
| K010633 | RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM | Mitek Products | 2001-05-09 | 68 | 0 |
| K002406 | MITEK 2GII MENISCAL REPAIR SYSTEM | Mitek Products | 2001-02-15 | 192 | 0 |
| K003076 | MITEK CUFFTACK | Mitek Products | 2000-10-27 | 24 | 0 |
| K002402 | VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTE | Mitek Products | 2000-08-31 | 24 | 0 |
| K002422 | VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM | Mitek Products | 2000-08-31 | 23 | 0 |
| K000936 | VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM | Mitek Products | 2000-04-19 | 27 | 0 |
| K993575 | RESOLVE QUICKANCHOR | Mitek Products | 1999-12-29 | 69 | 0 |
| K993327 | TALON ANCHOR SNAP-PAK | Mitek Products | 1999-12-16 | 73 | 0 |
| K993261 | TALON ANCHOR SNAP-PAK | Mitek Products | 1999-12-02 | 64 | 0 |
| K992623 | MITEK MINI ANCHOR | Mitek Products | 1999-11-02 | 89 | 0 |
| K992876 | VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM | Mitek Products | 1999-09-24 | 29 | 0 |
| K992611 | MITEK ROTATOR CUFF QUICKANCHOR PLUS | Mitek Products | 1999-09-22 | 49 | 0 |
| K992487 | MITEK MINI QUICKANCHOR PLUS | Mitek Products | 1999-09-21 | 57 | 0 |
| K992406 | VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM | Mitek Products | 1999-08-06 | 17 | 0 |
| K983818 | MITEK FASTIN RC ANCHOR | Mitek Products | 1998-11-23 | 25 | 0 |
| K982420 | MITEK MICRO ANCHOR | Mitek Products | 1998-08-24 | 70 | 0 |
| K974341 | MITEK BTB ABSORBABLE (PLA) CROSS PIN | Mitek Products | 1998-04-16 | 149 | 0 |
| K974291 | MITEK BTB ABSORBABLE (PLA) CROSS PIN | Mitek Products | 1998-03-05 | 111 | 0 |
| K974345 | MITEK KNOTLESS ANCHOR | Mitek Products | 1998-02-13 | 86 | 0 |
| K970119 | MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX | Mitek Products | 1998-01-30 | 381 | 0 |
| K974022 | VAPR | Mitek Products | 1998-01-12 | 90 | 0 |
| K973009 | MITEK NON ABSORBABLE POLYPROPYLENE H FIX | Mitek Products | 1997-11-10 | 89 | 0 |
| K970360 | MITEK SUTURE RETROGRADER | Mitek Products | 1997-03-10 | 38 | 0 |
| K964013 | MITEK ABSORBABLE TOGGLE ANCHOR | Mitek Products | 1997-02-24 | 140 | 0 |
| K962511 | MITEK MICRO ANCHOR | Mitek Products | 1996-11-06 | 132 | 0 |
| K961094 | MITEK THREADED ANCHOR (MODIFICATION) | Mitek Products | 1996-10-03 | 203 | 0 |
| K962793 | MITEK MICRO ANCHOR | Mitek Products | 1996-10-01 | 76 | 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