Mesa Laboratories, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Mesa Laboratories, Inc.” (first 2004, latest 2020), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 134 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 | 1 | 200 |
| 2013 | 2 | 162 |
| 2014 | 1 | 271 |
| 2015 | 1 | 192 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 61 |
| 2020 | 1 | 65 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mesa Laboratories, Inc. took a median 63 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FIZ | Meter, Conductivity, Non-Remote | 3 | 3 |
| FKH | Solution-Test Standard-Conductivity, Dialysis | 3 | 3 |
| FRC | Indicator, Biological Sterilization Process | 3 | 3 |
Review panels
Most recent Mesa Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201765 | SmartHDM-510 System | FIZ | 2020-09-02 | 65 |
| K191496 | TDS Standard Solution | FKH | 2019-08-05 | 61 |
| K150657 | Phoenix XL Dialysate Meter | FIZ | 2015-09-21 | 192 |
| K140589 | STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR | FRC | 2014-12-03 | 271 |
| K130100 | COMINED STANDARD SOLUTION | FKH | 2013-04-18 | 93 |
| K122362 | SMART-WELL INCUBATOR | FRC | 2013-03-26 | 232 |
| K112018 | SMART READ EZTEST STEAM | FRC | 2012-01-30 | 200 |
| K050812 | 90XL INSTRUMENTATION SYSTEM | FIZ | 2005-05-05 | 35 |
| K033330 | CONDUCTIVITY/TDS CALIBRATOR SOLUTION | FKH | 2004-02-27 | 134 |
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2017-05-12.
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.
- Mesa Medical, Inc. (7 510(k)s)
- Mesa Biotech, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mesa Laboratories, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Mesa Laboratories, Inc.” (first 2004, latest 2020), 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 Mesa Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mesa Laboratories, Inc. is 134 days.
Which FDA product codes appear under Mesa Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are FIZ (Meter, Conductivity, Non-Remote, 3); FKH (Solution-Test Standard-Conductivity, Dialysis, 3); FRC (Indicator, Biological Sterilization Process, 3).
Next steps
- See all 9 Mesa Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FIZ, Mesa Laboratories, 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.