Medical device manufacturer
Resmed Corporation
Resmed Corporation holds 125 FDA 510(k) clearances across 7 product codes. Median elapsed review time is 111 days. openFDA lists 14 recall records naming the company. FDA publishes it under 11 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 125
- Product codes
- 7
- Median review
- 111 days
- Recall records
- 14
How does FDA spell Resmed Corporation?
FDA publishes this company under 11 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| RESMED CORP | device/registrationlisting | normalised |
| RESMED PTY LTD. | device/registrationlisting | normalised |
| ResMed Corp | device/registrationlisting | normalised |
| ResMed Ltd. | device/enforcement | normalised |
| ResMed Ltd. | device/recall | normalised |
| Resmed Corp | device/510k | normalised |
| Resmed Corporation | device/enforcement | normalised |
| Resmed Corporation | device/recall | normalised |
Showing 8 of 11.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Resmed Corporation file in?
7 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 97 | 100 days | |
| MNS | Ventilator, Continuous, Non-Life-Supporting | 19 | 128 days | |
| CBK | Ventilator, Continuous, Facility Use | 4 | 166 days | |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 111 days | |
| LQZ | Device, Jaw Repositioning | 1 | 31 days | |
| MNT | Sv70 Ventilator | 1 | 246 days | |
| MQC | Mouthguard, Prescription | 1 | 234 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Resmed Corporation had a recall?
openFDA lists 14 recall records naming this company across its whole history, of which 1 was opened in the last 12 months and is not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2735-2026Open, ClassifiedCBK
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
Z-0536-2024Class IOpen, ClassifiedBZD
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
Z-0537-2024Class IOpen, ClassifiedBZD
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
Z-0538-2024Class IOpen, ClassifiedBZD
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
Z-0539-2024Class IOpen, ClassifiedBZD
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
Showing the 5 most recently initiated of 14.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Resmed Corporation cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K253553 | Orion | BZD | 202 | |
| K254104 | ResScan Essentials | BZD | 159 | |
| K251889 | myAir | MNS | 292 | |
| K251661 | Mariana Minerva; Mariana Nimbus | MNS | 269 | |
| K251657 | Personalized Therapy Comfort Settings (PTCS) | BZD | 189 | |
| K250624 | myAir | BZD | 86 | |
| K242547 | AirFit F20 Mask System; AirFit F20 NM Mask System | BZD | 265 | |
| K241939 | EasyCare Tx 2 | BZD | 87 | |
| K241216 | myAir | BZD | 148 | |
| K200565 | Galapogos | BZD | 319 |
Source: openFDA device/510k · retrieved
Where is Resmed Corporation registered?
FDA lists 3 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Resmed Corporation files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.