Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lepu Medical Technology (Beijing) Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
211 daysmedian FDA review time
447 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172331 | Type I, Type II, Type III, Type IV | Lepu Medical Technology (Beijing) Co., Ltd. | 2018-03-02 | 212 | 0 |
| K172099 | Shoocin Introducer Kit | Lepu Medical Technology (Beijing) Co., Ltd. | 2017-10-05 | 86 | 0 |
| K141707 | ULTRASKIN HYDROPHILIC GUIDE WIRE | Lepu Medical Technology (Beijing) Co., Ltd. | 2015-01-21 | 211 | 0 |
| K142359 | Vasc Band hemostat | Lepu Medical Technology (Beijing) Co., Ltd. | 2014-10-23 | 59 | 0 |
| K123475 | SHOOCIN INTRODUCER KIT | Lepu Medical Technology (Beijing) Co., Ltd. | 2014-02-03 | 447 | 0 |
| K123473 | HOPER PTCA BALLOON CATHETER | Lepu Medical Technology (Beijing) Co., Ltd. | 2013-08-13 | 273 | 0 |
| K111837 | RADIAL ARTERY COMPRESSION TOURNIQUET | Lepu Medical Technology (Beijing) Co., Ltd. | 2011-09-27 | 90 | 0 |
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