Mesa Medical, Inc.: FDA clearances and approvals
Mesa Medical, Inc. has 7 FDA 510(k) clearances (first 1982, latest 1994), across 4 product codes in 1 review panel. Median 510(k) review time: 75 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 |
|---|---|---|---|
| LIF | Dialyzer Reprocessing System | 3 | 3 |
| FLB | Meter, Conductivity, Induction, Remote Type | 2 | 2 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 1 | 1 |
| LRI | Ph Meter For Dialysis Hydrogen Ion Concentration | 1 | 1 |
Review panels
Most recent Mesa Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925210 | 90DX MULTITEST METER, MODIFICATION | FLB | 1994-01-25 | 475 |
| K882032 | MODEL 90DX MULTITEST METER | FLB | 1988-08-11 | 87 |
| K870811 | MODEL 102 PH METER | LRI | 1987-03-24 | 21 |
| K852749 | RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT | FKQ | 1985-09-10 | 75 |
| K843520 | WAREXIN RECOMMENDED ALTERNATIVE DIALYZ | LIF | 1984-10-04 | 27 |
| K834447 | ECHO MM1000 | LIF | 1984-03-23 | 98 |
| K821383 | ECHO, MODEL MM-1000 | LIF | 1982-06-23 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Mesa Medical, 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 Mesa Medical, Inc. have?
Mesa Medical, Inc. has 7 FDA 510(k) clearances (first 1982, latest 1994), across 4 product codes in 1 review panel.
How long does FDA take to clear Mesa Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Mesa Medical, Inc.'s cleared 510(k)s is 75 days.
What devices does Mesa Medical, Inc. make?
Its most frequent FDA product codes are LIF (Dialyzer Reprocessing System, 3); FLB (Meter, Conductivity, Induction, Remote Type, 2); FKQ (System, Dialysate Delivery, Central Multiple Patient, 1).
Has Mesa Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mesa Medical, Inc. Related entities may recall under other names.
Next steps
- See all 7 Mesa Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LIF, Mesa Medical, 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.