Mitek Products: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Mitek Products” (first 1996, latest 2002), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 74 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 7 | 7 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| HWC | Screw, Fixation, Bone | 4 | 4 |
| DZL | Screw, Fixation, Intraosseous | 3 | 3 |
| HTY | Pin, Fixation, Smooth | 3 | 3 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 3 | 3 |
| HRX | Arthroscope | 2 | 2 |
| JDR | Staple, Fixation, Bone | 2 | 2 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 1 | 1 |
| HWQ | Passer | 1 | 1 |
Review panels
- Orthopedic (22)
- General and Plastic Surgery (5)
- Dental (3)
Most recent Mitek Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013572 | MITEK BIOCRYL INTERFERENCE SCREWS | HWC | 2002-03-14 | 136 |
| K013781 | RIDIDFIX 2.7MM BTB CROSS PIN KIT | HTY | 2002-02-06 | 84 |
| K002639 | BIOKNOTLESS ANCHOR | GAM | 2001-05-11 | 260 |
| K010633 | RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM | HWC | 2001-05-09 | 68 |
| K002406 | MITEK 2GII MENISCAL REPAIR SYSTEM | MAI | 2001-02-15 | 192 |
| K003076 | MITEK CUFFTACK | MAI | 2000-10-27 | 24 |
| K002422 | VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM | GEI | 2000-08-31 | 23 |
| K002402 | VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM | HRX | 2000-08-31 | 24 |
| K000936 | VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM | GEI | 2000-04-19 | 27 |
| K993575 | RESOLVE QUICKANCHOR | DZL | 1999-12-29 | 69 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mitek Products.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Mitek Surgical Products, Inc. (31 510(k)s)
- Mitek Worldwide (10 510(k)s)
- Mitek , Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mitek Products?
FDA lists 30 510(k) clearances under the applicant name “Mitek Products” (first 1996, latest 2002), across 10 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mitek Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mitek Products is 74 days.
Which FDA product codes appear under Mitek Products?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 7); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); HWC (Screw, Fixation, Bone, 4).
Next steps
- See all 30 Mitek Products clearances with predicates and recalls
- Run predicate analysis for product code MBI, Mitek Products's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.