Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Caldera Medical, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
138 daysmedian FDA review time
344 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233500 | Benesta Tissue Removal Device | Caldera Medical, Inc. | 2023-11-30 | 30 | 0 |
| K211975 | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desar | Caldera Medical, Inc. | 2021-11-10 | 138 | 0 |
| K192811 | BenestaTM Tissue Removal Device | Caldera Medical, Inc. | 2020-10-23 | 389 | 0 |
| K192822 | Benesta Hysteroscope | Caldera Medical, Inc. | 2020-09-09 | 344 | 0 |
| K193603 | Benesta Medical Sterilization Tray | Caldera Medical, Inc. | 2020-07-20 | 210 | 0 |
| K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One | Caldera Medical, Inc. | 2020-02-07 | 255 | 0 |
| K172614 | Caldera Medical Transobturator Helical Introducer, Left; Cal | Caldera Medical, Inc. | 2018-05-04 | 246 | 0 |
| K162201 | Desara TV, Desara Blue TV | Caldera Medical, Inc. | 2017-01-11 | 159 | 0 |
| K150023 | Vertessa Lite Y-Mesh | Caldera Medical, Inc. | 2015-04-06 | 90 | 0 |
| K150016 | Vertessa Lite | Caldera Medical, Inc. | 2015-04-06 | 91 | 0 |
| K132069 | DESARA MESH, DESARA BLUE | Caldera Medical, Inc. | 2013-09-23 | 82 | 0 |
| K123028 | VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LI | Caldera Medical, Inc. | 2013-04-25 | 209 | 0 |
| K121928 | DESARA SL | Caldera Medical, Inc. | 2013-02-19 | 232 | 0 |
| K120327 | VERTESSA | Caldera Medical, Inc. | 2012-05-10 | 98 | 0 |
| K103418 | DESARA MINI | Caldera Medical, Inc. | 2011-11-30 | 373 | 0 |
| K112609 | DESARA MESH | Caldera Medical, Inc. | 2011-09-30 | 22 | 0 |
| K101462 | ASCEND BLUE AC MESH; ASCEND BLUE PC MESH | Caldera Medical, Inc. | 2010-08-16 | 82 | 0 |
| K101169 | DESARA MESH MODEL: CAL-DS01 | Caldera Medical, Inc. | 2010-05-20 | 24 | 0 |
| K083722 | ASCEND | Caldera Medical, Inc. | 2009-03-31 | 106 | 0 |
| K072456 | DESARA MESH SLING, MODEL CAL-DS01 | Caldera Medical, Inc. | 2008-05-08 | 251 | 0 |
| K053424 | POPMESH | Caldera Medical, Inc. | 2006-02-22 | 76 | 0 |
| K060004 | CALDERA MESH | Caldera Medical, Inc. | 2006-02-22 | 50 | 0 |
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