Tianjin Mastervision Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under 2 spellings of the applicant name “Tianjin Mastervision Technology Co., Ltd.” (first 2024, latest 2024), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 159 days. 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 |
|---|---|---|
| 2024 | 1 | 159 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tianjin Mastervision Technology Co., Ltd. took a median 159 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 76 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | 1 | 1 |
| NUU | Lens, Contact, Orthokeratology, Overnight | 1 | 0 |
Review panels
- Ophthalmic (2)
Most recent Tianjin Mastervision Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241398 | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses | HQD | 2024-10-22 | 159 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P220015 | PMA | DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens | 2026-08-05 |
Recalls
openFDA lists no recalls under a recalling firm named Tianjin Mastervision Technology Co., Ltd..
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Tianjin MasterVision Technology Co., Ltd. (1)
- Tianjin Mastervision Technology Co., Ltd. (1)
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.
- Tianjin Huahong Technology Co., Ltd. (16 510(k)s)
- Tianjin New Bay Bioresearch Co., Ltd. (11 510(k)s)
- Tianjin Empecs Medical Device Co., Ltd. (4 510(k)s)
- Tianjin Medis Medical Device Co., Ltd. (3 510(k)s)
- Tianjin Walkman Biomaterial Co., Ltd. (3 510(k)s)
- Tianjin Zhengtian Medical Instrument Co., Ltd. (3 510(k)s)
- Tianjin Aoshang Outdoor Equipment Co., Ltd. (2 510(k)s)
- Tianjin Rilifine Medical Device Co., Ltd. (2 510(k)s)
- Tianjin Uwell Medical Device Manufacturing Co., Ltd. (2 510(k)s)
- Tianjin Human-Care Latex Corporation (1 510(k)s)
- Tianjin Kepler Vehicle Industry Co. , Ltd. (1 510(k)s)
- Tianjin Medis International Trade Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tianjin Mastervision Technology Co., Ltd.?
FDA lists 1 510(k) clearance under 2 spellings of the applicant name “Tianjin Mastervision Technology Co., Ltd.” (first 2024, latest 2024), plus 1 PMA decision, across 2 product codes 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 Tianjin Mastervision Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tianjin Mastervision Technology Co., Ltd. is 159 days.
Which FDA product codes appear under Tianjin Mastervision Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are HQD (Lens, Contact (Other Material) - Daily, 1); NUU (Lens, Contact, Orthokeratology, Overnight, 1).
Next steps
- See all 1 Tianjin Mastervision Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HQD, Tianjin Mastervision Technology Co., Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.