Dexcom, Inc.: FDA filings under this applicant name

FDA lists 25 510(k) clearances under the applicant name “Dexcom, Inc.” (first 2018, latest 2026), plus 2 PMA and 3 De Novo decisions, across 10 product codes in 1 review panel. Median 510(k) review time under this name: 71 days. Since 2017 the median was 71 days, against 86 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 Dexcom, Inc. took a median 71 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 86 days.

Top product codes

Review panels

• Clinical Chemistry (30)

Most recent Dexcom, Inc. 510(k) clearances

15 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

29 product recalls in 11 recall events; 18 initiated in the last five years. Most recent: 2026-05-27.

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 Dexcom, Inc. is the lead sponsor of 18 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:

• NCT06483945: Dexcom Continuous Glucose Monitoring System Use in aReal-World, Global Registry (Dexcom Global Registry) (Recruiting, started 2024-02-28)
• NCT05746286: Remote Monitoring of Vital Signs With Telehealth to Prevent Readmissions for Dysglycemia (Completed, started 2023-02-01)
• NCT04794478: Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System (Completed, started 2021-02-19)
• NCT04840446: Evaluation of Modified Adhesives With Dexcom G6 Sensor (Completed, started 2021-02-08)
• NCT04585139: Assessing Non-adjunctive CGM Safety at Home and in New Markets (Completed, started 2020-10-06)

SEC filings

DEXCOM INC (DXCM): EDGAR filings, CIK 1093557. An SEC registrant with the same name, matched by name only.

Frequently asked questions

How many FDA 510(k) clearances are listed under Dexcom, Inc.?

FDA lists 25 510(k) clearances under the applicant name “Dexcom, Inc.” (first 2018, latest 2026), plus 2 PMA and 3 De Novo decisions, across 10 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 Dexcom, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Dexcom, Inc. is 71 days. Since 2017: 71 days, versus 86 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Dexcom, Inc.?

The most frequent FDA product codes under this applicant name are QBJ (Integrated Continuous Glucose Monitoring System, Factory Calibrated, 15); QDK (Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management, 4); MDS (Sensor, Glucose, Invasive, 2).

Next steps

• See all 25 Dexcom, Inc. clearances with predicates and recalls
• Run predicate analysis for product code QBJ, Dexcom, Inc.'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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