Medcare Medical Group, Inc.: FDA clearances and approvals
Medcare Medical Group, Inc. has 8 FDA 510(k) clearances (first 1996, latest 1998), across 8 product codes in 4 review panels. Median 510(k) review time: 71 days.
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 |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 1 | 1 |
| LRQ | Tracheostomy And Nasal Suctioning Kit | 1 | 1 |
Review panels
- General Hospital (4)
- General and Plastic Surgery (2)
- Anesthesiology (1)
- Dental (1)
Most recent Medcare Medical Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973497 | HUBERLOC | LJT | 1998-01-13 | 120 |
| K970152 | BIOPSY TRAY | FRG | 1997-03-05 | 48 |
| K962849 | CATHETER INSERTION TRAY | LJS | 1996-10-07 | 77 |
| K961075 | MEDCARE REGIONAL ANETHESIA KIT | CAZ | 1996-09-06 | 172 |
| K962328 | SINGLE USE INSTRUMENT TRAY | FSM | 1996-08-09 | 64 |
| K962527 | GENERAL PURPOSE DENTAL TRAY | EIA | 1996-08-01 | 35 |
| K961880 | MEDCARE SUCTION CONNECTING TUBING | GCX | 1996-07-19 | 65 |
| K961167 | MEDCARE TRACHEOSTOMY CARE TRAY | LRQ | 1996-07-02 | 99 |
Recalls
openFDA lists no recalls under a recalling firm named Medcare Medical Group, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Medcare Medical Group, Inc. have?
Medcare Medical Group, Inc. has 8 FDA 510(k) clearances (first 1996, latest 1998), across 8 product codes in 4 review panels.
How long does FDA take to clear Medcare Medical Group, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medcare Medical Group, Inc.'s cleared 510(k)s is 71 days.
What devices does Medcare Medical Group, Inc. make?
Its most frequent FDA product codes are CAZ (Anesthesia Conduction Kit, 1); EIA (Unit, Operative Dental, 1); FRG (Wrap, Sterilization, 1).
Has Medcare Medical Group, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medcare Medical Group, Inc. Related entities may recall under other names.
Next steps
- See all 8 Medcare Medical Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAZ, Medcare Medical Group, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.