Resmed, Ltd.: FDA filings under this applicant name
FDA lists 103 510(k) clearances under the applicant name “Resmed, Ltd.” (first 1996, latest 2019), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 109 days. Since 2017 the median was 186 days, against 240 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 | 7 | 120 |
| 2013 | 7 | 112 |
| 2014 | 6 | 156 |
| 2015 | 2 | 136 |
| 2016 | 8 | 160 |
| 2017 | 2 | 194 |
| 2018 | 3 | 217 |
| 2019 | 1 | 140 |
| 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 Resmed, Ltd. took a median 186 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 240 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 81 | 81 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | 16 | 16 |
| CBK | Ventilator, Continuous, Facility Use | 4 | 4 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| MNT | Sv70 Ventilator | 1 | 1 |
Review panels
- Anesthesiology (103)
Most recent Resmed, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183512 | Moore Park Mask | BZD | 2019-05-07 | 140 |
| K180497 | Scone Mask | BZD | 2018-06-15 | 109 |
| K172875 | Astral 100/150 | CBK | 2018-04-26 | 217 |
| K170924 | AirFit F20 | BZD | 2018-01-03 | 280 |
| K171212 | AirFit N20 | BZD | 2017-09-28 | 156 |
| K161492 | Juno VPAP ST-A | MNS | 2017-01-19 | 232 |
| K160836 | Menai System | BZD | 2016-12-15 | 265 |
| K161978 | AirFit N20 | BZD | 2016-11-17 | 122 |
| K161487 | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx | MNS | 2016-09-09 | 101 |
| K160822 | S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV | BZD | 2016-09-09 | 169 |
93 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 5 recall events; 9 initiated in the last five years. Most recent: 2026-06-25.
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.
- Resmed Corp (18 510(k)s)
- Resmed Germany, Inc. (8 510(k)s)
- Resmed Pty , Ltd. (3 510(k)s)
- Resmed Pty Ltd (Registration Number: 3004604967) (3 510(k)s)
- Resmed Sas (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Resmed, Ltd.?
FDA lists 103 510(k) clearances under the applicant name “Resmed, Ltd.” (first 1996, latest 2019), 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 Resmed, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Resmed, Ltd. is 109 days. Since 2017: 186 days, versus 240 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Resmed, Ltd.?
The most frequent FDA product codes under this applicant name are BZD (Ventilator, Non-Continuous (Respirator), 81); MNS (Ventilator, Continuous, Non-Life-Supporting, 16); CBK (Ventilator, Continuous, Facility Use, 4).
Next steps
- See all 103 Resmed, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BZD, Resmed, Ltd.'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.