510(k) Report

FDA applicant

Dexcom, Inc.

San Diego, CA28 decisions2006–202618 recalls

FDA records 28 decisions for Dexcom, Inc. (San Diego, CA) from 2006 to 2026: 25 510(k) clearances, 1 De Novo grant and 2 original PMA approvals. Most are in product codes QBJ (Integrated Continuous Glucose Monitoring…) and QDK (Integrated Continuous Glucose Monitoring…). Since 2016 its 510(k)s took a median of 25 days from receipt to decision, against 74 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 30 of them its own earlier devices. 18 recalls are linked to its devices, 6 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Dexcom, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2012: 12018: 32019: 42020: 22021: 22022: 22023: 22024: 32025: 32026 (partial year): 5
2007high 5 (2026) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2026

2019: 12020: 32021: 12025: 10, 6 Class I2026 (partial year): 3
2007high 10 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Dexcom, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dexcom, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QBJIntegrated Continuous Glucose Monitoring System, Factory Calibrated15decisions
  • QDKIntegrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management4decisions
  • SAFIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring…2decisions
  • MDSSensor, Glucose, Invasive2decisions
  • SBHIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Management…2decisions
  • QRXContinuous Glucose Monitor Informed Insulin Dose Calculator1decision

Also: QDL (1), QII (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 25 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 74 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 31 predicates; 30 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 33 times; 30 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN170088Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 20184cite it
  • K234070Stelo Glucose Biosensor SystemDexcom, Inc. · 20243cite it
  • K240902Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 20243cite it
  • K191450Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring…Dexcom, Inc. · 20193cite it
  • K200876Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc. · 20202cite it
  • K243214Dexcom G7 15 Day Continuous Glucose Monitoring SystemDexcom, Inc. · 20252cite it

What has FDA decided for it lately?

  • K262472Stelo Glucose Biosensor SystemDexcom, Inc. · 2026
  • K260935Stelo Glucose Biosensor SystemDexcom, Inc. · 2026
  • K261402Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring SystemDexcom, Inc. · 2026
  • K261359Stelo Glucose Biosensor SystemDexcom, Inc. · 2026
  • K253737Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM)…Dexcom, Inc. · 2026
  • K253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM)…Dexcom, Inc. · 2025
  • K252818Dexcom Smart BasalDexcom, Inc. · 2025
  • K243214Dexcom G7 15 Day Continuous Glucose Monitoring SystemDexcom, Inc. · 20252 recalls

All 28 as Dexcom, Inc. →

What has been recalled?

18 recalls linked to its devices; the latest:

  • K240902Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US…May 27, 2026Class II
  • K240902Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM…Apr 14, 2026Class II
  • K240902Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM…Apr 14, 2026Class II
  • K223931Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and…Aug 28, 2025Class I
  • K213919Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM…Jul 24, 2025Class I
  • K213919Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM…Jul 24, 2025Class I