510(k) · Cleared

Cleared

Steritec Integraph Model CI-101

K960441510(k) TraditionalCleared May 8, 1997462-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

Steritec Products Mfg Co, Inc. · JOJ Indicator, Physical/Chemical Sterilization Process

Cleared on May 8, 1997 after a 462-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.

Decided: May 8, 1997
Review: 462 days
Class: Class II
Product code: JOJ
Recalls: None
Predicates: 0

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

This deviceK960441 Steritec Integraph Model CI-101Steritec Products Mfg Co, Inc. · 1997
Descendant · cites it directly · 3 of its ownK070461 Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10…STERIS Corporation · 2007 · Recalled
Descendant · cites it directly · 2 of its ownK071895 Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSTERIS Corporation · 2007
Descendant · cites it directly · 1 of its ownK083643 Verify 275F Gravity IndicatorsSTERIS Corporation · 2009
Descendant · 2 generations on · 0 of its ownK182724 CelerityTM 10 STEAM Chemical IndicatorSTERIS Corporation · 2018
Descendant · 2 generations on · 0 of its ownK162758 VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators…STERIS Corporation · 2017 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 6 · See all

K070461Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4STERIS Corporation · 2007 · cites it directly3descendants
K071895Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSTERIS Corporation · 2007 · cites it directly2descendants
K083643Verify 275F Gravity IndicatorsSTERIS Corporation · 2009 · cites it directly1descendant
K182724CelerityTM 10 STEAM Chemical IndicatorSTERIS Corporation · 2018 · 2 generations on0descendants
K162758VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test…STERIS Corporation · 2017 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K960441	Steritec Integraph Model CI-101	Steritec Products Mfg Co, Inc.	1997	—
+1	K070461	Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4	STERIS Corporation	2007	1
+1	K071895	Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator	STERIS Corporation	2007	—
+1	K083643	Verify 275F Gravity Indicators	STERIS Corporation	2009	—
+2	K182724	CelerityTM 10 STEAM Chemical Indicator	STERIS Corporation	2018	—
+2	K162758	VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie…	STERIS Corporation	2017	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2009	1	0
2011	1	0
2017	1	0
2018	1	0

FIG. 1 — Lineage of K960441, 1997–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	ATI Steam C.I. Named without a submission number			—

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K070461	Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4	STERIS Corporation	2007	3
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, K070461 (STERIS Corporation, 2007) has gone furthest, with 3 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?

The Steritec Integraph is designed to provide an integrated response to steam sterilization at 132 C for sterilizers operating for 3 1/2 minutes or longer.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K960441 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960441: Steritec Integraph Model CI-101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960441

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026