Medcom GmbH: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Medcom GmbH” (first 2002, latest 2018), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 102 days, against 123 days for all cleared 510(k)s in the same product codes. 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 | 1 | 101 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 150 |
| 2018 | 2 | 66 |
| 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 Medcom GmbH took a median 102 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 3 | 3 |
| IYE | Accelerator, Linear, Medical | 2 | 2 |
| KPQ | System, Simulation, Radiation Therapy | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| MUJ | System, Planning, Radiation Therapy Treatment | 2 | 2 |
Review panels
- Radiology (11)
Most recent Medcom GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181789 | VeriSuite | LHN | 2018-09-21 | 78 |
| K180308 | Prelude | MUJ | 2018-03-27 | 53 |
| K170841 | BiopSee, Mobile US | LLZ | 2017-07-26 | 127 |
| K163119 | NaviSuite SSI Edition | LLZ | 2017-05-01 | 174 |
| K133914 | VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE | LHN | 2014-04-03 | 101 |
| K102237 | PVS MODEL 1.0 | IYE | 2010-11-23 | 106 |
| K100056 | MEDCOM RT-VIEWER SYSTEM | MUJ | 2010-05-07 | 119 |
| K092653 | VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 | LHN | 2009-09-18 | 21 |
| K080742 | VERISUITE 1.6, VERISUITE-PARTICLE 1.6 | IYE | 2008-05-09 | 53 |
| K032550 | EXOMIO, MODEL 2.0 SP1 | KPQ | 2003-09-25 | 38 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medcom GmbH.
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.
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.
- Medcom Diagnostics, Inc. (2 510(k)s)
- Medcom Laundry Service, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medcom GmbH?
FDA lists 11 510(k) clearances under the applicant name “Medcom GmbH” (first 2002, latest 2018), across 5 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 Medcom GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medcom GmbH is 90 days. Since 2017: 102 days, versus 123 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medcom GmbH?
The most frequent FDA product codes under this applicant name are LHN (System, Radiation Therapy, Charged-Particle, Medical, 3); IYE (Accelerator, Linear, Medical, 2); KPQ (System, Simulation, Radiation Therapy, 2).
Next steps
- See all 11 Medcom GmbH clearances with predicates and recalls
- Run predicate analysis for product code LHN, Medcom 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.