Leonhard Lang GmbH: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Leonhard Lang GmbH” (first 1999, latest 2014), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 52 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 | 3 | 99 |
| 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 10 | 10 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 5 | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| GXY | Electrode, Cutaneous | 1 | 1 |
Review panels
- Cardiovascular (15)
- General and Plastic Surgery (3)
- Neurology (1)
Most recent Leonhard Lang GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142803 | Skintact, various other tradenames | MKJ | 2014-12-02 | 64 |
| K140500 | SKINTACT | GEI | 2014-07-29 | 152 |
| K140340 | SKINTACT | GXY | 2014-05-21 | 99 |
| K103186 | SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES | MKJ | 2011-02-08 | 102 |
| K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES | DRX | 2009-08-21 | 23 |
| K081371 | SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL | MKJ | 2008-09-24 | 132 |
| K080106 | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE | DRX | 2008-02-01 | 17 |
| K073104 | SKINTACT AND VARIOUS OTHER TRADENAMES | DRX | 2007-11-16 | 14 |
| K072233 | SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS | MKJ | 2007-10-05 | 56 |
| K063161 | SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL | GEI | 2006-11-21 | 35 |
9 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2014-12-03.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Leonhard Lang GmbH?
FDA lists 19 510(k) clearances under the applicant name “Leonhard Lang GmbH” (first 1999, latest 2014), across 4 product codes in 3 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 Leonhard Lang GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Leonhard Lang GmbH is 52 days.
Which FDA product codes appear under Leonhard Lang GmbH?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 10); MKJ (Automated External Defibrillators (Non-Wearable), 5); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3).
Next steps
- See all 19 Leonhard Lang GmbH clearances with predicates and recalls
- Run predicate analysis for product code DRX, Leonhard Lang GmbH'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.