Caldera Medical, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Caldera Medical, Inc.” (first 2006, latest 2023), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 110 days. Since 2017 the median was 228 days, against 136 days for all cleared 510(k)s in the same product codes. 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 | 98 |
| 2013 | 4 | 161 |
| 2014 | 1 | 90 |
| 2015 | 2 | 90 |
| 2016 | 0 | — |
| 2017 | 1 | 159 |
| 2018 | 1 | 246 |
| 2019 | 0 | — |
| 2020 | 4 | 300 |
| 2021 | 1 | 138 |
| 2022 | 0 | — |
| 2023 | 1 | 30 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Caldera Medical, Inc. took a median 228 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 8 | 8 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | 5 | 5 |
| FTL | Mesh, Surgical, Polymeric | 3 | 3 |
| HIH | Hysteroscope (And Accessories) | 3 | 3 |
| PAH | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling | 2 | 2 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| OTP | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed | 1 | 1 |
| PWJ | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence | 1 | 1 |
Review panels
- Gastroenterology and Urology (11)
- Obstetrics and Gynecology (9)
- General and Plastic Surgery (3)
- General Hospital (1)
Most recent Caldera Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233500 | Benesta Tissue Removal Device | HIH | 2023-11-30 | 30 |
| K211975 | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System | OTN | 2021-11-10 | 138 |
| K192811 | BenestaTM Tissue Removal Device | HIH | 2020-10-23 | 389 |
| K192822 | Benesta Hysteroscope | HIH | 2020-09-09 | 344 |
| K193603 | Benesta Medical Sterilization Tray | KCT | 2020-07-20 | 210 |
| K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack | PAH | 2020-02-07 | 255 |
| K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left | PWJ | 2018-05-04 | 246 |
| K162201 | Desara TV, Desara Blue TV | OTN | 2017-01-11 | 159 |
| K150023 | Vertessa Lite Y-Mesh | OTO | 2015-04-06 | 90 |
| K150016 | Vertessa Lite | OTO | 2015-04-06 | 91 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Caldera Medical, Inc..
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.
Device clinical trials
An industry sponsor named Caldera Medical, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04772131: Desara ® One Single Incision Sling 522 Study (Recruiting, started 2021-11-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Caldera Medical, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Caldera Medical, Inc.” (first 2006, latest 2023), across 8 product codes in 4 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 Caldera Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Caldera Medical, Inc. is 110 days. Since 2017: 228 days, versus 136 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Caldera Medical, Inc.?
The most frequent FDA product codes under this applicant name are OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, 8); OTO (Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed, 5); FTL (Mesh, Surgical, Polymeric, 3).
Next steps
- See all 24 Caldera Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OTN, Caldera Medical, 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.