Mitek Worldwide: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Mitek Worldwide” (first 2002, latest 2004), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 5 | 5 |
| JDR | Staple, Fixation, Bone | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 1 | 1 |
| NOV | Anchor, Suture, Bone Fixation, Metallic | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Mitek Worldwide 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032717 | BIOCRYL RAPIDE INTERFERENCE SCREW | HWC | 2004-03-31 | 211 |
| K032167 | BIO-INTRAFIX TIBIAL SCREW AND SHEATH | HWC | 2003-10-15 | 91 |
| K032078 | MITEK MICRO QUICKANCHOR | NOV | 2003-08-25 | 49 |
| K030995 | MINILOK QUICKANCHOR PLUS | HWC | 2003-06-26 | 87 |
| K031519 | CUFFLOK ANCHOR | MAI | 2003-06-06 | 22 |
| K031406 | EXOJET TISSUE MANAGEMENT SYSTEM | HRX | 2003-05-30 | 25 |
| K024115 | MICROFIX QUICKANCHOR PLUS | HWC | 2003-03-13 | 90 |
| K023388 | MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM | JDR | 2002-12-27 | 79 |
| K021953 | MITEK PDS/PGA STAPLE | JDR | 2002-12-20 | 190 |
| K021883 | BIOFASTIN RC THREADED SUTURE ANCHOR | HWC | 2002-07-01 | 24 |
Recalls
6 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2003-06-16.
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 Products (30 510(k)s)
- Mitek , Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mitek Worldwide?
FDA lists 10 510(k) clearances under the applicant name “Mitek Worldwide” (first 2002, latest 2004), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mitek Worldwide?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mitek Worldwide is 83 days.
Which FDA product codes appear under Mitek Worldwide?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 5); JDR (Staple, Fixation, Bone, 2); HRX (Arthroscope, 1).
Next steps
- See all 10 Mitek Worldwide clearances with predicates and recalls
- Run predicate analysis for product code HWC, Mitek Worldwide'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.