510(k) · Cleared

Cleared

Steam Sterilization Intergrator

K012195510(k) TraditionalCleared May 7, 2002298-day reviewClass II21 CFR 880.2800

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

Dana Products, Inc. · JOJ Indicator, Physical/Chemical Sterilization Process

Cleared on May 7, 2002 after a 298-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.

Decided: May 7, 2002
Review: 298 days
Class: Class II
Product code: JOJ
Recalls: None
Predicates: 0

10 later devices descend from it, 3 citing it directly.

This deviceK012195 Steam Sterilization IntergratorDana Products, Inc. · 2002
Descendant · cites it directly · 5 of its ownK152630 VERIFY STEAM Integrating IndicatorSTERIS Corporation · 2016 · Recalled
Descendant · 2 generations on · 2 of its ownK162631 VERIFY STEAM Integrating Indicator - ShortSTERIS Corporation · 2017
Descendant · cites it directly · 2 of its ownK071895 Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSTERIS Corporation · 2007
Descendant · 2 generations on · 1 of its ownK213412 VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating…Steris Corparation · 2022
Descendant · 2 generations on · 1 of its ownK200252 Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg Co, Inc. · 2020

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2007high 2 (2017) · low 0 (2008)2026

Most influential descendants

Showing 5 of 10 · See all

K152630VERIFY STEAM Integrating IndicatorSTERIS Corporation · 2016 · cites it directly5descendants
K162631VERIFY STEAM Integrating Indicator - ShortSTERIS Corporation · 2017 · 2 generations on2descendants
K071895Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSTERIS Corporation · 2007 · cites it directly2descendants
K213412VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CMSteris Corparation · 2022 · 2 generations on1descendant
K200252Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg Co, Inc. · 2020 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K012195	Steam Sterilization Intergrator	Dana Products, Inc.	2002	—
+1	K152630	VERIFY STEAM Integrating Indicator	STERIS Corporation	2016	1
+2	K162631	VERIFY STEAM Integrating Indicator - Short	STERIS Corporation	2017	—
+1	K071895	Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator	STERIS Corporation	2007	—
+2	K213412	VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM	Steris Corparation	2022	—
+2	K200252	Getinge Assured MI Steam Migrating Integrator	Steritec Products Mfg Co, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	1	0
2011	1	0
2016	1	0
2017	2	0
2020	1	0
2022	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K012195, 2002–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JOJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JOJ device

#1 K261992 3M™ Attest™ Steam Chemical Integrator (1243A…score 13.3 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (10)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K152630	VERIFY STEAM Integrating Indicator	STERIS Corporation	2016	5
K071895	Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator	STERIS Corporation	2007	2
K083643	Verify 275F Gravity Indicators	STERIS Corporation	2009	1

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K152630 (STERIS Corporation, 2016) has gone furthest, with 5 descendants of its own.

How does its category compare?

All JOJ devices

JOJ Indicator, Physical/Chemical Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOJ

6in 2025

2007high 13 (2011) · low 4 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOJ

90in 2025

2007high 224 (2012) · low 38 (2019)2026

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

Recalls per year · JOJ

1in 2023

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	140	0	1
2008	9	57	2	1
2009	7	188	2	9
2010	6	115	0	3
2011	13	151	2	1
2012	7	224	0	8
2013	6	212	0	6
2014	6	198	0	11
2015	8	188	0	7
2016	4	150	0	11
2017	7	172	0	35
2018	5	150	0	12
2019	12	38	0	8
2020	7	108	0	6
2021	4	87	1	29
2022	8	90	0	23
2023	4	53	1	39
2024	12	71	0	25
2025	6	90	0	12
2026	3	30	0	—

What is it indicated for?

Dana Steam Sterilization Integrators are intended to be used to monitor critical parameters in steam sterilization cycles in healthcare facilities. The critical parameters for which the integrators will respond are time and temperature (when steam is present). The end point is determined by the migration of the steam sensitive dye to an area marked safe on the indicator. The integrators are intended to be used in 30 minute gravity cycles at 250 degrees F and 3 minute gravity and pre- vacuum cycles at 270 degrees F.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012195 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012195: Steam Sterilization Intergrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012195

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026