Dongguan TT Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Dongguan TT Medical, Inc.” (first 2023, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 124 days. Since 2017 the median was 124 days, against 140 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 |
|---|---|---|
| 2023 | 4 | 162 |
| 2024 | 1 | 113 |
| 2025 | 0 | — |
| 2026 | 1 | 37 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dongguan TT Medical, Inc. took a median 124 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OZT | Balloon Aortic Valvuloplasty | 3 | 3 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| KTI | Bronchoscope Accessory | 1 | 1 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 1 | 1 |
Review panels
Most recent Dongguan TT Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260437 | Valvuloplasty Balloon Catheter (ValvuloPro) | OZT | 2026-03-20 | 37 |
| K240967 | ValvuloPro Valvuloplasty Balloon Catheter | OZT | 2024-07-31 | 113 |
| K231814 | ValvuloPro Valvuloplasty Balloon Catheter | OZT | 2023-10-12 | 113 |
| K230374 | Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) | LOX | 2023-06-29 | 136 |
| K222663 | MultiStage Balloon Dilatation Catheter | FGE | 2023-03-09 | 188 |
| K222187 | Multistage Balloon Dilatation Catheter | KTI | 2023-03-01 | 222 |
Recalls
openFDA lists no recalls under a recalling firm named Dongguan TT 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Dongguan TT Medical, Inc. (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Dongguan Prestige Sporting Goods Co., Ltd. (12 510(k)s)
- Dongguan E-Test Technology Co., Ltd. (5 510(k)s)
- Dongguan Boyuan Intelligent Technology Co.,Ltd (4 510(k)s)
- Dongguan Simzo Electronic Technology Co., Ltd. (3 510(k)s)
- Dongguan Ageless Health Industrial Co., Ltd. (2 510(k)s)
- Dongguan Hunter Electronic Technology Co., Ltd. (2 510(k)s)
- Dongguan Kangweile Electronic Technology Co., Ltd. (2 510(k)s)
- Dongguan Lide Electric Appliance Co., Ltd. (2 510(k)s)
- Dongguan Shin YI Healthcare Products Factory (2 510(k)s)
- Dongguan Smarfody Mobility Technology Co., Ltd. (2 510(k)s)
- Dongguan Tutamen Metalwork Co., Ltd. (2 510(k)s)
- Dongguan Xiangtong Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dongguan TT Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Dongguan TT Medical, Inc.” (first 2023, latest 2026), across 4 product codes in 3 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 Dongguan TT Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dongguan TT Medical, Inc. is 124 days. Since 2017: 124 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Dongguan TT Medical, Inc.?
The most frequent FDA product codes under this applicant name are OZT (Balloon Aortic Valvuloplasty, 3); FGE (Stents, Drains And Dilators For The Biliary Ducts, 1); KTI (Bronchoscope Accessory, 1).
Next steps
- See all 6 Dongguan TT Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OZT, Dongguan TT 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.