Luther Medical Products, Inc.: FDA clearances and approvals
Luther Medical Products, Inc. has 17 FDA 510(k) clearances (first 1980, latest 1998), across 8 product codes in 4 review panels. Median 510(k) review time: 112 days.
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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 6 | 6 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 4 | 4 |
| DYB | Introducer, Catheter | 2 | 2 |
| DQR | Cannula, Catheter | 1 | 1 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| GCD | Connector, Catheter | 1 | 1 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 1 | 1 |
| LKX | Device, Thermal, Hemorrhoids | 1 | 1 |
Review panels
- General Hospital (11)
- Cardiovascular (4)
- Gastroenterology and Urology (1)
- General and Plastic Surgery (1)
Most recent Luther Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982797 | BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB | DYB | 1998-11-30 | 112 |
| K980090 | ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) | LJS | 1998-03-24 | 74 |
| K974543 | L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER | FOZ | 1998-02-10 | 69 |
| K940198 | L-CATH CONNECTOR ASSEMBLY | GCD | 1994-12-15 | 336 |
| K942103 | L-CATH CATHETER SYSTEM - PORT L-CATH | LJT | 1994-07-26 | 85 |
| K930473 | ONECATH L-CATH CATHETER SYSTEM | LJS | 1994-04-07 | 434 |
| K925236 | L CATH(R) CATHETER SYSTEM | LJS | 1994-03-22 | 522 |
| K920755 | L-CATH PEEL AWAY SYSTEM CATHETER | LJS | 1993-06-07 | 474 |
| K925979 | DUAL LUMEN L-CATH CATHETER SYSTEM | DQX | 1993-05-27 | 183 |
| K924968 | L-CATH PEEL-AWAY CATHETER SYSTEM | FOZ | 1993-05-21 | 233 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Luther Medical Products, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Luther Medical Products, Inc. have?
Luther Medical Products, Inc. has 17 FDA 510(k) clearances (first 1980, latest 1998), across 8 product codes in 4 review panels.
How long does FDA take to clear Luther Medical Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Luther Medical Products, Inc.'s cleared 510(k)s is 112 days.
What devices does Luther Medical Products, Inc. make?
Its most frequent FDA product codes are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 6); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 4); DYB (Introducer, Catheter, 2).
Has Luther Medical Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Luther Medical Products, Inc. Related entities may recall under other names.
Next steps
- See all 17 Luther Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Luther Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.