510(k) Report

FDA product code · Clinical chemistry

Electrode, Ion Specific, Calcium

JFPClass II21 CFR 862.1145510(k) required29 decisions since 19774 recalls

29 FDA decisions since 1977. 510(k) reviews decided 2021–2025 took a median of 266 days (half between 266 and 266). 4 recalls name this code, 0 of them Class I. The most-cited predicate is K972673, named by 7 later devices.

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 JFP 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 · JFP

1in 2023

2016: 12019: 12020: 12023: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JFP

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

Recalls per year · JFP

1in 2011

2008: 12011: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JFP

40in 2025

2008: 52009: 52010: 22011: 82013: 12014: 12015: 32017: 22018: 52019: 62020: 62022: 62023: 22024: 82025: 40
2007high 40 (2025) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—15
20090—05
20100—02
20110—18
20120—00
20130—01
20140—01
20150—03
20161—00
20170—02
20180—05
20191—06
20201—06
20210—00
20220—06
20231—02
20240—08
20250—040
20260—0—
FIG. 1 — JFP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JFP? 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 862.1145.