FDA product code · Clinical chemistry

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

Name: FDA decisions, review times, recalls and adverse event reports for product code SAF
Creator: 510(k) Report

SAFClass II21 CFR 862.1355510(k) required4 decisions since 20240 recalls

4 FDA decisions since 2024. 510(k) reviews decided 2021–2025 took a median of 74 days (half between 70 and 136). No recall names this code. The most-cited predicate is K234070, named by 3 later devices.

An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose monitoring is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels in persons who are not on insulin and do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose monitoring are…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical chemistry panel

Twenty years of SAF at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · SAF

1in 2025

2007high 2 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SAF

Too few SAF 510(k)s in any year since 2007 to give a median.

Recalls per year · SAF

No recall names SAF since 2007.

Adverse event reports per year · SAF

1,481in 2025

2007high 1,481 (2025) · low 0 (2007)2025

MAUDE reports naming product code SAF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	2	—	249
2025	1	—	1,481
2026	1	—	—

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

Planning a device in SAF? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 862.1355.

QDK Integrated Continuous Glucose Monitoring…QII Integrated Continuous Glucose Monitoring…QDL Integrated Continuous Glucose Monitoring…SBH Integrated Continuous Glucose Monitor For…QLG Integrated Continuous Glucose Monitoring…QBJ Integrated Continuous Glucose Monitoring…

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

Which predicates do SAF devices cite most?

Which SAF devices have the deepest lineage?

What has FDA decided in SAF lately?

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