Medcare Products: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Medcare Products” (first 1981, latest 1984), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 38 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 |
|---|---|---|---|
| FSM | Tray, Surgical, Instrument | 5 | 5 |
| KDC | Instrument, Surgical, Disposable | 4 | 4 |
| GEN | Forceps, General & Plastic Surgery | 2 | 2 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 2 | 2 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FZT | Cutter, Surgical | 1 | 1 |
| FZX | Guide, Surgical, Instrument | 1 | 1 |
| HRQ | Hemostat | 1 | 1 |
| JOK | Scissors, Medical, Disposable | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Medcare Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841122 | TRACHEOSTOMY CARE TRAY | FSM | 1984-04-25 | 41 |
| K841124 | DIALYSIS TRAY | KOC | 1984-04-20 | 36 |
| K841123 | DRESSING CHANGE TRAY | FRG | 1984-04-17 | 33 |
| K831374 | MED CARE PREP RAZOR | — | 1983-10-04 | 160 |
| K831663 | TISSUE FORCEPS | KOC | 1983-09-26 | 126 |
| K831665 | DISPOSABLE NEEDLE HOLDER | KDC | 1983-09-12 | 112 |
| K831664 | PLASTIC THUMB FORCEPS | KDC | 1983-09-12 | 112 |
| K831661 | DISPOSABLE SCISSORS | KDC | 1983-08-25 | 94 |
| K831662 | DISPOSABLE HEMOSTAT (STRAIGHT&CURVED | KDC | 1983-07-19 | 57 |
| K823854 | MEDCARE SUTURE REMOVAL TRAYS | FSM | 1983-03-31 | 99 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medcare 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.
- Medcare Custom Packaging, Inc. (11 510(k)s)
- Medcare Medical Group, Inc. (8 510(k)s)
- Medcare Disp Products, Inc. (6 510(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 Products?
FDA lists 20 510(k) clearances under the applicant name “Medcare Products” (first 1981, latest 1984), across 10 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 Medcare Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medcare Products is 38 days.
Which FDA product codes appear under Medcare Products?
The most frequent FDA product codes under this applicant name are FSM (Tray, Surgical, Instrument, 5); KDC (Instrument, Surgical, Disposable, 4); GEN (Forceps, General & Plastic Surgery, 2).
Next steps
- See all 20 Medcare Products clearances with predicates and recalls
- Run predicate analysis for product code FSM, Medcare 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.