Envitec-Wismar GmbH: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Envitec-Wismar GmbH” (first 2000, latest 2014), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 154 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 | 177 |
| 2014 | 1 | 217 |
| 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 |
|---|---|---|---|
| DQA | Oximeter | 7 | 7 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 2 | 2 |
Review panels
- Anesthesiology (9)
Most recent Envitec-Wismar GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133064 | MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31 | DQA | 2014-05-02 | 217 |
| K122290 | ENVITEC MYSIGN O OXYGEN MEASURING DEVICE | CCL | 2013-01-23 | 177 |
| K102270 | ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN | DQA | 2011-02-22 | 196 |
| K090438 | REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR | DQA | 2009-07-24 | 154 |
| K082655 | ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 | CCL | 2008-11-25 | 74 |
| K070193 | ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES | DQA | 2007-05-02 | 100 |
| K060675 | ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS | DQA | 2006-07-17 | 125 |
| K043463 | ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS | DQA | 2005-02-11 | 58 |
| K992215 | MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED | DQA | 2000-03-29 | 272 |
Recalls
openFDA lists no recalls under a recalling firm named Envitec-Wismar 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Envitec-Wismar GmbH?
FDA lists 9 510(k) clearances under the applicant name “Envitec-Wismar GmbH” (first 2000, latest 2014), across 2 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 Envitec-Wismar GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Envitec-Wismar GmbH is 154 days.
Which FDA product codes appear under Envitec-Wismar GmbH?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 7); CCL (Analyzer, Gas, Oxygen, Gaseous-Phase, 2).
Next steps
- See all 9 Envitec-Wismar GmbH clearances with predicates and recalls
- Run predicate analysis for product code DQA, Envitec-Wismar 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.