Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Dexcom, Inc. — Predicate Candidate Screening

27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

74 daysmedian FDA review time

308 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260935	Stelo Glucose Biosensor System	Dexcom, Inc.	2026-06-12	84	0
K261402	Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15	Dexcom, Inc.	2026-06-08	40	0
K261359	Stelo Glucose Biosensor System	Dexcom, Inc.	2026-05-21	27	0
K253737	Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom	Dexcom, Inc.	2026-02-03	71	0
K253710	Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom	Dexcom, Inc.	2025-12-17	23	0
K252818	Dexcom Smart Basal	Dexcom, Inc.	2025-11-18	75	0
K243214	Dexcom G7 15 Day Continuous Glucose Monitoring System	Dexcom, Inc.	2025-04-09	188	2
K240902	Dexcom G7 Continuous Glucose Monitoring System	Dexcom, Inc.	2024-04-23	21	3
K234070	Stelo Glucose Biosensor System	Dexcom, Inc.	2024-03-05	74	0
K234133	Dexcom G7 Continuous Glucose Monitoring System	Dexcom, Inc.	2024-02-26	59	0
K231081	Dexcom G7 Continuous Glucose Monitoring (CGM) System	Dexcom, Inc.	2023-05-15	28	1
K223931	Dexcom G6 Continuous Glucose Monitoring (CGM) System	Dexcom, Inc.	2023-01-11	12	5
K213919	Dexcom G7 Continuous Glucose Monitoring System	Dexcom, Inc.	2022-12-07	357	4
K221259	Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom	Dexcom, Inc.	2022-07-29	88	0
K203089	Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM	Dexcom, Inc.	2021-08-17	308	0
K201328	Dexcom G6 Continuous Glucose Monitoring (CGM) System	Dexcom, Inc.	2021-07-15	422	0
K200876	Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Gl	Dexcom, Inc.	2020-12-04	247	0
K193642	Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM	Dexcom, Inc.	2020-01-29	30	0
K192787	Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM	Dexcom, Inc.	2019-10-25	25	0
K191833	Dexcom G6 Pro Continuous Glucose Monitoring System	Dexcom, Inc.	2019-10-07	90	0
K191450	Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Gl	Dexcom, Inc.	2019-06-28	28	0
K183206	Dexcom G6 Continuous Glucose Monitoring System	Dexcom, Inc.	2019-02-14	87	0
K182405	Dexcom Pro Q Continuous Glucose Monitoring System	Dexcom, Inc.	2018-11-02	59	0
K182041	Dexcom G6 Glucose Program Continuous Glucose Monitoring Syst	Dexcom, Inc.	2018-10-26	88	0
DEN170088	Dexcom G6 Continuous Glucose Monitoring System	Dexcom, Inc.	2018-03-27	109	0
DEN140038	Dexcom Share Direct Secondary Displays	Dexcom, Inc.	2015-01-23	39	0
DEN140016	STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE	Dexcom, Inc.	2014-08-19	119	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda