510(k) · Cleared

Cleared

Instant Readout Chemical Integrator Challenge Pack, Model LT- 105

K080136510(k) TraditionalCleared Aug 15, 2008206-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, Inc. · JOJ Indicator, Physical/Chemical Sterilization Process

Cleared on Aug 15, 2008 after a 206-day review. The FDA summary names no predicate by number. 2 later devices descend from it.

Decided: Aug 15, 2008
Review: 206 days
Class: Class II
Product code: JOJ
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK080136 Instant Readout Chemical Integrator Challenge Pack, Model LT- 105Steritec Products, Inc. · 2008
Descendant · cites it directly · 1 of its ownK103053 Verify 270FP Challenge PackSTERIS Corporation · 2011 · Recalled
Descendant · 2 generations on · 0 of its ownK162758 VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators…STERIS Corporation · 2017 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K103053Verify 270FP Challenge PackSTERIS Corporation · 2011 · cites it directly1descendant
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)	K080136	Instant Readout Chemical Integrator Challenge Pack, Model LT- 105	Steritec Products, Inc.	2008	—
+1	K103053	Verify 270FP Challenge Pack	STERIS Corporation	2011	1
+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
2011	1	0
2017	1	0

FIG. 1 — Lineage of K080136, 2008–2017Source: 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?

The FDA summary names no predicate by number.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K103053	Verify 270FP Challenge Pack	STERIS Corporation	2011	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, K103053 (STERIS Corporation, 2011) has gone furthest, with 1 descendant 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. 2008, this device’s year, is highlighted.

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 Instant Readout Chemical Integrator Challenge Pack is a steam sterilization process challenge device that meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs The Integrator Challenge Pack monitors pre-vacuum steam sterilizers operating at 132°C (270 0 F) or 135°C (275 0 F). When exposed to steam sterilization conditions the Instant Readout Chemical Integrator card gives an integrated response by changing from purple to green. The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080136 · printed Nov 4, 2026

Cite this page

510(k) Report. “K080136: Instant Readout Chemical Integrator Challenge Pack, Model LT- 105.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080136

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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