Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mesa Laboratories, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
134 daysmedian FDA review time
271 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201765 | SmartHDM-510 System | Mesa Laboratories, Inc. | 2020-09-02 | 65 | 0 |
| K191496 | TDS Standard Solution | Mesa Laboratories, Inc. | 2019-08-05 | 61 | 0 |
| K150657 | Phoenix XL Dialysate Meter | Mesa Laboratories, Inc. | 2015-09-21 | 192 | 0 |
| K140589 | STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR | Mesa Laboratories, Inc. | 2014-12-03 | 271 | 0 |
| K130100 | COMINED STANDARD SOLUTION | Mesa Laboratories, Inc. | 2013-04-18 | 93 | 0 |
| K122362 | SMART-WELL INCUBATOR | Mesa Laboratories, Inc. | 2013-03-26 | 232 | 0 |
| K112018 | SMART READ EZTEST STEAM | Mesa Laboratories, Inc. | 2012-01-30 | 200 | 0 |
| K050812 | 90XL INSTRUMENTATION SYSTEM | Mesa Laboratories, Inc. | 2005-05-05 | 35 | 0 |
| K033330 | CONDUCTIVITY/TDS CALIBRATOR SOLUTION | Mesa Laboratories, Inc. | 2004-02-27 | 134 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda