# Alton (Shanghai) Medical Instruments Co., Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 6 (2023–2025): 6 510(k) clearances
- Product codes: KTI (1), FAD (1), PKL (1), ODC (1), FBK (1), FDS (1)
- 510(k) review time since 2016: median 242 days, against 179 for FDA's reviews in the same codes and years (0 of 6 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 0 (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
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Hangzhou AGS MedTech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-ags-medtech)
- Sml Med-Tech Solutions Limited: 1 (https://510kreport.com/company/sml-med-tech-solutions)
- Anrei Medical (Hangzhou) Co., Ltd.: 1 (https://510kreport.com/company/anrei-medical-hangzhou)
- Fujifilm Medical Systems U.S.A, Inc.: 1 (https://510kreport.com/company/fujifilm-medical-systems-usa)

## Recent decisions
- K243039: Ureteral Stents (AF-D series) (Jun 18, 2025)
- K242635: Endoscopic Distal Attachment (AF-D series) (May 30, 2025)
- K241679: Disposable Cytology Brush (AF series) (Mar 4, 2025)
- K241285: Disposable Endoscope Valves Set (AF series) (Oct 1, 2024)
- K231633: Disposable Hemoclip (AF series) (Jan 11, 2024)
- K230925: Disposable Injection Needle AF series (Sep 27, 2023)

Source page: https://510kreport.com/company/alton-shanghai-medical-instruments