Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Shenzhen HugeMed Medical Technical Development Co., Ltd. · Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

207 daysmedian FDA review time
287 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.2026-05-14570
K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.2025-07-081230
K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2025-01-212440
K240374Ureterorenoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2024-05-10930
K232435Rhinolaryngoscope systemShenzhen HugeMed Medical Technical Development Co., Ltd.2024-04-262560
K231497Choledochoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2024-03-062870
K231118Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2023-11-132070
K222910Bronchoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2023-04-111970

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