Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Gimbo Medical Technology Shenzhen Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
146 daysmedian FDA review time
263 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253121 | Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Doub | Gimbo Medical Technology Shenzhen Co., Ltd. | 2026-06-15 | 263 | 0 |
| K242043 | Sperm Freezing Medium | Gimbo Medical Technology Shenzhen Co., Ltd. | 2025-01-08 | 180 | 0 |
| K242968 | Giftlife® Single-Step Medium Plus | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-11-22 | 57 | 0 |
| K240002 | G-Vitri™ Vitrification Straw | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-06-14 | 164 | 0 |
| K240149 | Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; G | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-06-13 | 146 | 0 |
| K234023 | Oocyte Flushing & Retrieval Medium; Gamete Buffer | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-05-10 | 142 | 0 |
| K232942 | G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-01-30 | 132 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda