Resmed, Ltd.: FDA filings under this applicant name

FDA lists 121 510(k) clearances under the applicant name “Resmed, Ltd.” (first 1996, latest 2026), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 111 days. Since 2017 the median was 159 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Resmed, Ltd. took a median 159 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

Review panels

• Anesthesiology (121)

Most recent Resmed, Ltd. 510(k) clearances

111 earlier clearances. See the full list in Caduvo.

Recalls

14 product recalls in 8 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.

Device clinical trials

An industry sponsor named Resmed, Ltd. is the lead sponsor of 70 device studies on ClinicalTrials.gov (6 active or recruiting). Most recent:

• NCT07011966: ASV Therapy for Insomnia (Recruiting, started 2026-03-01)
• NCT06769607: Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study (Recruiting, started 2025-04-10)
• NCT06173050: PAP Systems Internal Clinical Studies (ICS) (Completed, started 2024-06-20)
• NCT03924817: Registry Study on Prescription, Patient Pathways, Therapy Efficacy and Usage of Mandibular Advancement Devices in Obstructive Sleep Apnea - PATT-OSA Registry (Recruiting, started 2024-02-01)
• NCT06079866: Oran Park Mask External Clinical Study (3) Marketing Claims Study (Completed, started 2023-10-04)

SEC filings

RESMED INC (RMD, RSMDF): EDGAR filings, CIK 943819. An SEC registrant with the same name, matched by name only.

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 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 121 510(k) clearances under the applicant name “Resmed, Ltd.” (first 1996, latest 2026), across 6 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 111 days. Since 2017: 159 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), 95); MNS (Ventilator, Continuous, Non-Life-Supporting, 18); CBK (Ventilator, Continuous, Facility Use, 4).

Next steps

• See all 121 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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