Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Vitavitro Biotech Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
196 daysmedian FDA review time
266 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240523 | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, O | Shenzhen Vitavitro Biotech Co., Ltd. | 2024-11-15 | 266 | 0 |
| K240307 | VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A | Shenzhen Vitavitro Biotech Co., Ltd. | 2024-08-16 | 196 | 0 |
| K212410 | VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Med | Shenzhen Vitavitro Biotech Co., Ltd. | 2022-02-01 | 182 | 0 |
| K200408 | VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Me | Shenzhen Vitavitro Biotech Co., Ltd. | 2020-10-16 | 240 | 0 |
| K191063 | 1-Step Culture Medium | Shenzhen Vitavitro Biotech Co., Ltd. | 2019-08-23 | 123 | 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