510(k) Report

FDA product code · General hospital

Indicator, Physical/Chemical Sterilization Process

JOJClass II21 CFR 880.2800510(k) required267 decisions since 197615 recalls

267 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 84 days (half between 30 and 139). 15 recalls name this code, 0 of them Class I. The most-cited predicate is K921910, named by 5 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, general hospital panel

Twenty years of JOJ 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 · JOJ

6in 2025

2007: 82008: 92009: 72010: 62011: 132012: 72013: 62014: 62015: 82016: 42017: 72018: 52019: 122020: 72021: 42022: 82023: 42024: 122025: 62026 (partial year): 3
2007high 13 (2011) · low 4 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOJ

90in 2025

2007: 140 days median2008: 57 days median2009: 188 days median2010: 115 days median2011: 151 days median2012: 224 days median2013: 212 days median2014: 198 days median2015: 188 days median2016: 150 days median2017: 172 days median2018: 150 days median2019: 38 days median2020: 108 days median2021: 87 days median2022: 90 days median2023: 53 days median2024: 71 days median2025: 90 days median2026 (partial year): 30 days median
2007high 224 (2012) · low 38 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOJ

1in 2023

2008: 22009: 22011: 22021: 12023: 1
2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JOJ

12in 2025

2007: 12008: 12009: 92010: 32011: 12012: 82013: 62014: 112015: 72016: 112017: 352018: 122019: 82020: 62021: 292022: 232023: 392024: 252025: 12
2007high 39 (2023) · low 1 (2007)2025

MAUDE reports naming product code JOJ, 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
2007814001
200895721
2009718829
2010611503
20111315121
2012722408
2013621206
20146198011
2015818807
20164150011
20177172035
20185150012
2019123808
2020710806
2021487129
2022890023
2023453139
20241271025
2025690012
20263300—
FIG. 1 — JOJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JOJ? 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 880.2800.