Atlas FDA

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

Yibin Junxin Electronics Technology Co., Ltd. · Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K211532Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33Yibin Junxin Electronics Technology Co., Ltd.2022-01-192460
K203662Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11Yibin Junxin Electronics Technology Co., Ltd.2021-09-232820

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