Mark One Healthcare Products: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Mark One Healthcare Products” (first 1977, latest 1989), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| FMP | Protector, Skin Pressure | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| KME | Bedding, Disposable, Medical | 1 | 1 |
| LGF | Component, Cast | 1 | 1 |
Review panels
Most recent Mark One Healthcare Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891986 | MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE | KME | 1989-12-29 | 276 |
| K833867 | PAREMA K BAND NON-STERILE | EFQ | 1984-01-27 | 81 |
| K833084 | MASTERHINGE | LGF | 1983-10-14 | 31 |
| K770396 | DRAPES, MODESTY | KKX | 1977-03-23 | 22 |
| K761268 | SKIN PRESSURE PROTECTORS | FMP | 1977-02-16 | 62 |
Recalls
openFDA lists no recalls under a recalling firm named Mark One Healthcare 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.
- Mark Abramson, D.D.S., Inc. (2 510(k)s)
- Mark H. Friedman (2 510(k)s)
- Mark Solutions, Inc. (1 510(k)s)
- Mark Sullivan, M.D., P.C. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mark One Healthcare Products?
FDA lists 5 510(k) clearances under the applicant name “Mark One Healthcare Products” (first 1977, latest 1989), 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 Mark One Healthcare Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mark One Healthcare Products is 62 days.
Which FDA product codes appear under Mark One Healthcare Products?
The most frequent FDA product codes under this applicant name are EFQ (Gauze/Sponge, Internal, 1); FMP (Protector, Skin Pressure, 1); KKX (Drape, Surgical, Antimicrobial, 1).
Next steps
- See all 5 Mark One Healthcare Products clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Mark One Healthcare 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.