# Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

- Location (FDA's records): Beijing, CN
- FDA decisions: 7 (2020–2024): 7 510(k) clearances
- Product codes: GCJ (2), GDW (1), LZA (1), FXX (1), FYA (1), NPL (1)
- 510(k) review time since 2016: median 147 days, against 113 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.: 2 (https://510kreport.com/company/bjzh-f-panther-medical-equipment)
- Showa Best Glove, Inc.: 1 (https://510kreport.com/company/showa-best-glove)
- Fengh Medical Co., Ltd.: 1 (https://510kreport.com/company/fengh-medical)
- V&Q Manufacturing Corporation: 1 (https://510kreport.com/company/v-q-manufacturing)
- Gmax Industries, Inc.: 1 (https://510kreport.com/company/gmax-industries)
- Cook Biotech, Inc.: 1 (https://510kreport.com/company/cook-biotech)
- Beijing Hangtian Kadi Technology R&D Institute: 1 (https://510kreport.com/company/beijing-hangtian-kadi-technology-r-d-institute)

## Firms that cite its devices most
- Shandong Haidike Medical Products Co., Ltd.: 1 (https://510kreport.com/company/shandong-haidike-medical-products)
- Mediconcepts Technology (Shenzhen) Company Limited: 1 (https://510kreport.com/company/mediconcepts-technology-shenzhen)
- Lyncmed Medical Technology (Beijing) Co., Ltd.: 1 (https://510kreport.com/company/lyncmed-medical-technology-beijing)
- Wujiang Tutaike Textiles & Finishing Co., Ltd.: 1 (https://510kreport.com/company/wujiang-tutaike-textiles-finishing)
- Veol Medical Technologies Pvt, Ltd.: 1 (https://510kreport.com/company/veol-medical-technologies-pvt)
- Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi: 1 (https://510kreport.com/company/feliks-plastik-laminasyon-ve-ambalaj-malzemeleri-sanayi)

## Its most-cited devices
- K202029: Medical Surgical Mask (2020), cited by 2
- K202844: Medical Surgical Gowns (2021), cited by 2
- K201641: Disposable Laparoscope Trocar (2020), cited by 1
- K201243: Disposable Specimen Retrieval Bag (2020), cited by 1

## Recent decisions
- K231513: Oral Matrix (Feb 16, 2024)
- K203622: Medical Gloves (Aug 20, 2021)
- K201639: Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads (May 27, 2021)
- K202844: Medical Surgical Gowns (Jan 6, 2021)
- K202029: Medical Surgical Mask (Dec 16, 2020)
- K201641: Disposable Laparoscope Trocar (Aug 6, 2020)
- K201243: Disposable Specimen Retrieval Bag (Jul 10, 2020)

Source page: https://510kreport.com/company/beijing-biosis-healing-biolog-ical-technology