Medicare Industries, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Medicare Industries, Inc.” (first 1978, latest 1989), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 12 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | 4 | 4 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
| KDC | Instrument, Surgical, Disposable | 1 | 1 |
Review panels
Most recent Medicare Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K894197 | LATEX EXAMINATION GLOVES | LYY | 1989-08-24 | 70 |
| K891865 | NIL (PATIENT EXAMINATION GLOVES - LATEX) | LYY | 1989-05-25 | 59 |
| K791434 | SPONGE COUNTER BAGS | KDC | 1979-10-09 | 70 |
| K781981 | DECONTAMINATION ITEMS BAG | FRG | 1978-12-07 | 10 |
| K781980 | RESPIRATORY THERAPY GAS POUCH | FRG | 1978-12-07 | 10 |
| K781925 | POUCHES, GAS STERILIZATION | FRG | 1978-11-22 | 12 |
| K781924 | POUCHES AND TUBING, MEDI-SEAL | FRG | 1978-11-22 | 12 |
Recalls
openFDA lists no recalls under a recalling firm named Medicare Industries, 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 Medicare Industries, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Medicare Industries, Inc.” (first 1978, latest 1989), across 3 product codes in 2 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 Medicare Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medicare Industries, Inc. is 12 days.
Which FDA product codes appear under Medicare Industries, Inc.?
The most frequent FDA product codes under this applicant name are FRG (Wrap, Sterilization, 4); LYY (Latex Patient Examination Glove, 2); KDC (Instrument, Surgical, Disposable, 1).
Next steps
- See all 7 Medicare Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRG, Medicare Industries, 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.