Tianjin Huahong Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Tianjin Huahong Technology Co., Ltd.” (first 2021, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 62 days. Since 2017 the median was 62 days, against 118 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 |
|---|---|---|
| 2021 | 1 | 452 |
| 2022 | 4 | 98 |
| 2023 | 0 | — |
| 2024 | 3 | 25 |
| 2025 | 2 | 20 |
| 2026 | 6 | 61 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tianjin Huahong Technology Co., Ltd. took a median 62 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 8 | 8 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 5 | 5 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| MMK | Container, Sharps | 1 | 1 |
Review panels
Most recent Tianjin Huahong Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262526 | Safety lancet (XL) | FMK | 2026-09-13 | 53 |
| K262135 | Lancing device | QRL | 2026-08-18 | 54 |
| K260845 | Huahong Sharps Container (HHR-I, HHR-II) | MMK | 2026-08-05 | 142 |
| K262211 | Lancet | QRL | 2026-07-22 | 22 |
| K260191 | Safety lancet (XXXVII) | FMK | 2026-03-31 | 68 |
| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | FMK | 2026-02-12 | 188 |
| K253706 | Lancing device (HH-XV-T) | QRL | 2025-12-09 | 15 |
| K251694 | safety lancet | FMK | 2025-06-26 | 24 |
| K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) | QRL | 2024-11-15 | 25 |
| K241627 | Safety Lancet (XXXV) | FMK | 2024-06-20 | 14 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tianjin Huahong 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.
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 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 MasterVision Technology Co., Ltd. (1 510(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 Huahong Technology Co., Ltd.?
FDA lists 16 510(k) clearances under the applicant name “Tianjin Huahong Technology Co., Ltd.” (first 2021, latest 2026), across 4 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 Tianjin Huahong Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tianjin Huahong Technology Co., Ltd. is 62 days. Since 2017: 62 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tianjin Huahong Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, 8); QRL (Multiple Use Blood Lancet For Single Patient Use Only, 5); FMI (Needle, Hypodermic, Single Lumen, 2).
Next steps
- See all 16 Tianjin Huahong Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FMK, Tianjin Huahong 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, 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.