Leocor, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Leocor, Inc.” (first 1990, latest 1992), plus 1 PMA decision, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 174 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQI | Withdrawal/Infusion Pump | 1 | 1 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DXK | Echocardiograph | 1 | 1 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 1 | 0 |
Review panels
- Cardiovascular (3)
- General Hospital (1)
Most recent Leocor, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924110 | LEOCOR CORFLO PUMP -- MODIFICATION | DQI | 1992-09-01 | 90 |
| K911270 | LEOCOR GUIDING CATHETER | DQO | 1992-01-17 | 301 |
| K900350 | LEOCOR CORFLO(TM) PUMP | DXK | 1990-07-17 | 174 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P890001 | PMA | LEOCOR,INC. MODELS 1 | 1990-03-30 |
Recalls
openFDA lists no recalls under a recalling firm named Leocor, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Leocor, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via DQI)
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via DQI)
Frequently asked questions
How many FDA 510(k) clearances are listed under Leocor, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Leocor, Inc.” (first 1990, latest 1992), plus 1 PMA decision, across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Leocor, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Leocor, Inc. is 174 days.
Which FDA product codes appear under Leocor, Inc.?
The most frequent FDA product codes under this applicant name are DQI (Withdrawal/Infusion Pump, 1); DQO (Catheter, Intravascular, Diagnostic, 1); DXK (Echocardiograph, 1).
Next steps
- See all 3 Leocor, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQI, Leocor, Inc.'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.