Resmed Germany, Inc.: FDA clearances and approvals
Resmed Germany, Inc. has 8 FDA 510(k) clearances (first 2006, latest 2015), across 2 product codes in 1 review panel. Median 510(k) review time: 130 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 118 |
| 2013 | 2 | 210 |
| 2014 | 0 | — |
| 2015 | 1 | 167 |
| 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 |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | 5 | 5 |
| MNT | Sv70 Ventilator | 3 | 3 |
Review panels
- Anesthesiology (8)
Most recent Resmed Germany, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143272 | ApneaLink Air | MNR | 2015-04-30 | 167 |
| K131932 | APNEALINK PRO | MNR | 2013-11-08 | 134 |
| K122715 | STELLAR 150 | MNT | 2013-06-17 | 285 |
| K113640 | STELLAR 150 | MNT | 2012-04-05 | 118 |
| K103167 | STELLAR 150 | MNT | 2011-03-01 | 125 |
| K083575 | APNEALINK PLUS, MODEL: 22328 | MNR | 2009-03-19 | 106 |
| K070263 | APNEALINK | MNR | 2007-06-15 | 140 |
| K061405 | APNEALINK, MODEL 22302 | MNR | 2006-07-25 | 67 |
Recalls
openFDA lists no recalls under a recalling firm named Resmed Germany, 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 Resmed Germany, Inc. have?
Resmed Germany, Inc. has 8 FDA 510(k) clearances (first 2006, latest 2015), across 2 product codes in 1 review panel.
How long does FDA take to clear Resmed Germany, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Resmed Germany, Inc.'s cleared 510(k)s is 130 days.
What devices does Resmed Germany, Inc. make?
Its most frequent FDA product codes are MNR (Ventilatory Effort Recorder, 5); MNT (Sv70 Ventilator, 3).
Has Resmed Germany, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Resmed Germany, Inc. Related entities may recall under other names.
Next steps
- See all 8 Resmed Germany, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MNR, Resmed Germany, 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.