Siesta Medical, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Siesta Medical, Inc.” (first 2010, latest 2021), across 1 product code in 1 review panel. Median 510(k) review time under this name: 100 days. Since 2017 the median was 148 days, against 148 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 | 2 | 172 |
| 2013 | 0 | — |
| 2014 | 1 | 114 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 161 |
| 2020 | 1 | 148 |
| 2021 | 1 | 85 |
| 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 Siesta Medical, Inc. took a median 148 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 148 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ORY | Tongue Suspension System | 10 | 10 |
Review panels
- Dental (10)
Most recent Siesta Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213159 | Encore System | ORY | 2021-12-22 | 85 |
| K201238 | Encore System | ORY | 2020-10-02 | 148 |
| K183310 | Encore System | ORY | 2019-05-09 | 161 |
| K133680 | ENCORE SYSTEM | ORY | 2014-03-26 | 114 |
| K121440 | ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT | ORY | 2012-12-06 | 205 |
| K121814 | ENCORE TONGUE SUSPENSION SYSTEM | ORY | 2012-11-07 | 140 |
| K111179 | ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN | ORY | 2011-07-01 | 65 |
| K110127 | PRELUDE III TONGUE SUSPENSION SYSTEM | ORY | 2011-04-08 | 80 |
| K103179 | PRELUDE II TOUNGE SUSPENSION SYSTEM | ORY | 2010-12-20 | 53 |
| K101060 | SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM | ORY | 2010-07-08 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Siesta 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Siesta Medical, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Siesta Medical, Inc.” (first 2010, latest 2021), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Siesta Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siesta Medical, Inc. is 100 days. Since 2017: 148 days, versus 148 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Siesta Medical, Inc.?
The most frequent FDA product codes under this applicant name are ORY (Tongue Suspension System, 10).
Next steps
- See all 10 Siesta Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ORY, Siesta 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.