Lepu Medical Technology (Beijing) Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Lepu Medical Technology (Beijing) Co., Ltd.” (first 2011, latest 2018), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 211 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 273 |
| 2014 | 2 | 253 |
| 2015 | 1 | 211 |
| 2016 | 0 | — |
| 2017 | 1 | 86 |
| 2018 | 1 | 212 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Lepu Medical Technology (Beijing) Co., Ltd. took a median 149 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYB | Introducer, Catheter | 3 | 3 |
| DXC | Clamp, Vascular | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Lepu Medical Technology (Beijing) Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172331 | Type I, Type II, Type III, Type IV | DYB | 2018-03-02 | 212 |
| K172099 | Shoocin Introducer Kit | DYB | 2017-10-05 | 86 |
| K141707 | ULTRASKIN HYDROPHILIC GUIDE WIRE | DQX | 2015-01-21 | 211 |
| K142359 | Vasc Band hemostat | DXC | 2014-10-23 | 59 |
| K123475 | SHOOCIN INTRODUCER KIT | DYB | 2014-02-03 | 447 |
| K123473 | HOPER PTCA BALLOON CATHETER | LOX | 2013-08-13 | 273 |
| K111837 | RADIAL ARTERY COMPRESSION TOURNIQUET | DXC | 2011-09-27 | 90 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-04-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Lepu Medical Technology (Beijing) Co., Ltd. is the lead sponsor of 4 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07051811: To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension (Recruiting, started 2025-02-25)
- NCT06017349: To Evaluate the Efficacy and Safety of Multi-parameter Non-Invasive Glucose Sensors for for Blood Glucose Measurement (Completed, started 2022-09-21)
- NCT05202977: Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System (Enrolling by invitation, started 2021-04-06)
- NCT02536326: LEPU Renal Denervation System for Resistant Hypertension (Completed, started 2012-11)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Lepu Medical Technology (Beijing) Co., Ltd. (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Lepu Medical Technology (Bejing) Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lepu Medical Technology (Beijing) Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Lepu Medical Technology (Beijing) Co., Ltd.” (first 2011, latest 2018), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lepu Medical Technology (Beijing) Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lepu Medical Technology (Beijing) Co., Ltd. is 211 days.
Which FDA product codes appear under Lepu Medical Technology (Beijing) Co., Ltd.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 3); DXC (Clamp, Vascular, 2); DQX (Wire, Guide, Catheter, 1).
Next steps
- See all 7 Lepu Medical Technology (Beijing) Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Lepu Medical Technology (Beijing) Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.