Compumedics Limited: FDA filings under this applicant name

FDA lists 9 510(k) clearances under the applicant name “Compumedics Limited” (first 2000, latest 2025), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 184 days. Since 2017 the median was 184 days, against 183 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 Compumedics Limited took a median 184 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 183 days.

Top product codes

Review panels

• Neurology (5)
• Anesthesiology (4)

Most recent Compumedics Limited 510(k) clearances

Recalls

openFDA lists no recalls under a recalling firm named Compumedics Limited.

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 Compumedics Limited is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT05647746: Comparative Assessment of Compumedics Somfit Sleep Monitoring Device (Completed, started 2022-12-10)
• NCT04326127: Evaluation of Compumedics "Somfit" Device (Completed, started 2019-11-06)
• NCT01210261: New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults (Completed, started 2011-05)

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.

• Compumedics USA, Ltd. (3 510(k)s)
• Compumedics Germany Gmgh (1 510(k)s)
• Compumedics Neuro Science Pty , Ltd. (1 510(k)s)
• Compumedics Ptd , Ltd. (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Compumedics Limited?

FDA lists 9 510(k) clearances under the applicant name “Compumedics Limited” (first 2000, latest 2025), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Compumedics Limited?

The median time from FDA receipt to decision across 510(k)s cleared under the name Compumedics Limited is 184 days. Since 2017: 184 days, versus 183 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Compumedics Limited?

The most frequent FDA product codes under this applicant name are MNR (Ventilatory Effort Recorder, 4); GWQ (Full-Montage Standard Electroencephalograph, 2); OLV (Standard Polysomnograph With Electroencephalograph, 2).

Next steps

• See all 9 Compumedics Limited clearances with predicates and recalls
• Run predicate analysis for product code MNR, Compumedics Limited'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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