Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

ZheJiang Decans Medical Devices Co., Ltd. · Predicate Candidate Screening

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

244 daysmedian FDA review time
260 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.2026-06-162670
K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.2026-06-022490
K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd.2026-05-272540
K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.2026-05-272440
K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.2026-05-142540
K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.2026-04-292600
K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.2026-04-202030
K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.2026-04-152250
K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PZheJiang Decans Medical Devices Co., Ltd.2025-01-31650
K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.2024-11-041010
K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.2024-10-08680

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