Gimbo Medical Technology Shenzhen Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Gimbo Medical Technology Shenzhen Co., Ltd.” (first 2024, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 146 days. Since 2017 the median was 146 days, against 198 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 |
|---|---|---|
| 2024 | 5 | 142 |
| 2025 | 1 | 180 |
| 2026 | 1 | 263 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Gimbo Medical Technology Shenzhen Co., Ltd. took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 198 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQL | Media, Reproductive | 5 | 5 |
| MQE | Needle, Assisted Reproduction | 1 | 1 |
| MQK | Labware, Assisted Reproduction | 1 | 1 |
Review panels
Most recent Gimbo Medical Technology Shenzhen Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253121 | Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle | MQE | 2026-06-15 | 263 |
| K242043 | Sperm Freezing Medium | MQL | 2025-01-08 | 180 |
| K242968 | Giftlife® Single-Step Medium Plus | MQL | 2024-11-22 | 57 |
| K240002 | G-Vitri Vitrification Straw | MQK | 2024-06-14 | 164 |
| K240149 | Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium | MQL | 2024-06-13 | 146 |
| K234023 | Oocyte Flushing & Retrieval Medium; Gamete Buffer | MQL | 2024-05-10 | 142 |
| K232942 | G-Vitri Vitrification Freeze Media; G-Vitri Vitrification Thawing Media | MQL | 2024-01-30 | 132 |
Recalls
openFDA lists no recalls under a recalling firm named Gimbo Medical Technology Shenzhen 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Gimbo Medical Technology Shenzhen Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Gimbo Medical Technology Shenzhen Co., Ltd.” (first 2024, latest 2026), across 3 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 Gimbo Medical Technology Shenzhen Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gimbo Medical Technology Shenzhen Co., Ltd. is 146 days. Since 2017: 146 days, versus 198 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Gimbo Medical Technology Shenzhen Co., Ltd.?
The most frequent FDA product codes under this applicant name are MQL (Media, Reproductive, 5); MQE (Needle, Assisted Reproduction, 1); MQK (Labware, Assisted Reproduction, 1).
Next steps
- See all 7 Gimbo Medical Technology Shenzhen Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MQL, Gimbo Medical Technology Shenzhen 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.