FDA applicant
Hangzhou Kangji Medical Instrument Co., Ltd.
FDA records 3 decisions for Hangzhou Kangji Medical Instrument Co., Ltd. (Hangzhou, CN) from 2023 to 2025: 3 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HIF (Insufflator, Laparoscopic). Since 2016 its 510(k)s took a median of 193 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hangzhou Kangji Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Hangzhou Kangji Medical Instrument…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report