Medcare Disp Products, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Medcare Disp Products, Inc.” (first 1982, latest 1984), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 19 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 |
|---|---|---|---|
| FMF | Syringe, Piston | 3 | 3 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| KYZ | Syringe, Irrigating (Non Dental) | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (5)
Most recent Medcare Disp Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841949 | DOSE RELEASE OF STERILIZATION LOTS | FMF | 1984-09-05 | 114 |
| K841405 | INJECTION CAP OR ADAPTOR | — | 1984-04-04 | 0 |
| K840924 | SYRINGE, PISTON, ARTERIAL BLOOD SAMPL | FMF | 1984-03-23 | 21 |
| K821529 | DISPOSABLE HYPODERMIC NEEDLES | FMI | 1982-06-09 | 19 |
| K821528 | SYRINGE, PISTON | FMF | 1982-06-09 | 19 |
| K821530 | SYRINGE IRRIGATING | KYZ | 1982-05-28 | 7 |
Recalls
openFDA lists no recalls under a recalling firm named Medcare Disp Products, 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.
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.
- Medcare Products (20 510(k)s)
- Medcare Custom Packaging, Inc. (11 510(k)s)
- Medcare Medical Group, Inc. (8 510(k)s)
- Medcare Flaga (4 510(k)s)
- Medcare Manufacturing, Inc. (1 510(k)s)
- Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medcare Disp Products, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Medcare Disp Products, Inc.” (first 1982, latest 1984), across 4 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 Medcare Disp Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medcare Disp Products, Inc. is 19 days.
Which FDA product codes appear under Medcare Disp Products, Inc.?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 3); FMI (Needle, Hypodermic, Single Lumen, 1); KYZ (Syringe, Irrigating (Non Dental), 1).
Next steps
- See all 6 Medcare Disp Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Medcare Disp Products, 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.