Medikmark, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Medikmark, Inc.” (first 1992, latest 1995), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 441 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 3 | 3 |
| KOH | Instrument, Manual, General Obstetric-Gynecologic | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 | 1 |
Review panels
Most recent Medikmark, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953474 | IV START KIT | FPA | 1995-10-02 | 70 |
| K923960 | UPPER EXTERMITY DRAPE KIT | KKX | 1994-10-07 | 792 |
| K921733 | TRACHEOSTOMY CARE TRAY | JOH | 1994-06-15 | 796 |
| K921732 | MINOR LAP SET | KOH | 1994-06-15 | 796 |
| K921730 | C-SECTION PACK | KOH | 1994-06-15 | 796 |
| K920341 | LACERATION TRAYS | KKX | 1992-04-23 | 90 |
| K920340 | SUTURE REMOVAL KIT | KKX | 1992-04-23 | 90 |
| K920339 | DRESSING CHANGE TRAY | FRG | 1992-04-23 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Medikmark, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Medikmark, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Medikmark, Inc.” (first 1992, latest 1995), across 5 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 Medikmark, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medikmark, Inc. is 441 days.
Which FDA product codes appear under Medikmark, Inc.?
The most frequent FDA product codes under this applicant name are KKX (Drape, Surgical, Antimicrobial, 3); KOH (Instrument, Manual, General Obstetric-Gynecologic, 2); FPA (Set, Administration, Intravascular, 1).
Next steps
- See all 8 Medikmark, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KKX, Medikmark, Inc.'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.