Thd Spa: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Thd Spa” (first 2008, latest 2021), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 50 days. Since 2017 the median was 44 days, against 126 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 | 49 |
| 2013 | 1 | 9 |
| 2014 | 0 | — |
| 2015 | 1 | 249 |
| 2016 | 0 | — |
| 2017 | 1 | 258 |
| 2018 | 1 | 50 |
| 2019 | 0 | — |
| 2020 | 1 | 39 |
| 2021 | 1 | 29 |
| 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 Thd Spa took a median 44 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FER | Anoscope And Accessories | 5 | 5 |
| JAF | Monitor, Ultrasonic, Nonfetal | 3 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | 2 | 2 |
| FHN | Ligator, Hemorrhoidal | 1 | 1 |
Review panels
Most recent Thd Spa 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211623 | THD Procto Software System | IYO | 2021-06-24 | 29 |
| K193512 | THD Procto Software System | IYO | 2020-01-26 | 39 |
| K180135 | THD Anopress with THD SensyProbe | KLA | 2018-03-08 | 50 |
| K161785 | THD ANOPRESS | KLA | 2017-03-14 | 258 |
| K141657 | THD REVOLUTION | JAF | 2015-02-24 | 249 |
| K133687 | THD N-ANO ANOSCOPE | FER | 2013-12-11 | 9 |
| K121135 | THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE | FER | 2012-06-01 | 49 |
| K103647 | THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES | FER | 2011-03-01 | 78 |
| K093497 | THD BANDY | FHN | 2010-07-15 | 245 |
| K091490 | FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES | FER | 2009-06-11 | 22 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Thd Spa.
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 Thd Spa?
FDA lists 13 510(k) clearances under the applicant name “Thd Spa” (first 2008, latest 2021), across 5 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 Thd Spa?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thd Spa is 50 days. Since 2017: 44 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Thd Spa?
The most frequent FDA product codes under this applicant name are FER (Anoscope And Accessories, 5); JAF (Monitor, Ultrasonic, Nonfetal, 3); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2).
Next steps
- See all 13 Thd Spa clearances with predicates and recalls
- Run predicate analysis for product code FER, Thd Spa'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.