Atlas FDA

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

Coreleader Biotech Co., Ltd. · Predicate Candidate Screening

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

216 daysmedian FDA review time
338 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K151204HEMO-BandageCoreleader Biotech Co., Ltd.2015-07-31870
K141382BIOS KING BIOCELLULOSE FILMCoreleader Biotech Co., Ltd.2015-02-102590
K123394CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSINGCoreleader Biotech Co., Ltd.2013-06-062160
K111578CORELEADER COLLA-ALGI FIBER MODEL CAWCoreleader Biotech Co., Ltd.2011-09-231080
K111733CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.2011-09-22930
K102944CORELEADER HEMO-PAD MODEL CPII 02030Coreleader Biotech Co., Ltd.2011-09-073380
K102942CORELEADER ALGIPLASTER MODEL AP 050501Coreleader Biotech Co., Ltd.2011-06-222610
K102946CORELEADER COLLA-PAD MODEL CS 03030Coreleader Biotech Co., Ltd.2011-05-202280
K102943CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050Coreleader Biotech Co., Ltd.2011-04-121900

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