510(k) Report

FDA product code · Clinical chemistry

Electrode Measurement, Drain Effluent Ph

SFOClass II21 CFR 862.1120510(k) required1 decision since 20250 recalls

1 FDA decision since 2025. 510(k) reviews decided 2021–2025 took a median of 241 days (half between 241 and 241). No recall names this code.

Measurement of drain effluent pH

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 SFO 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 · SFO

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SFO

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

Recalls per year · SFO

No recall names SFO since 2007.

Adverse event reports per year · SFO

No MAUDE report names SFO since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20251—00
20260—0—
FIG. 1 — SFO by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SFO? 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 862.1120.