510(k) · Cleared

Recalled · 2009

Cross-Checks P

K972300510(k) TraditionalCleared Mar 25, 1998279-day reviewClass II21 CFR 880.2800Recalls 1

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 Mar 25, 1998 as substantially equivalent to K921910 (Johnson & Johnson Medical, Inc., 1993) after a 279-day review. Its family tree reaches back 1 generation to 1993. It has been recalled once.

Decided: Mar 25, 1998
Review: 279 days
Class: Class II
Product code: JOJ
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K921910 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
This deviceK972300 Cross-Checks PSteritec Products Mfg Co, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K921910	Sterrad Chemical Indicator	Johnson & Johnson Medical, Inc.	1993	—
0 (this device)	K972300	Cross-Checks P	Steritec Products Mfg Co, Inc.	1998	—

FIG. 1 — Lineage of K972300, 1993–1998Source: 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

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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
*	K921910	Sterrad Chemical Indicator Summary page 2 …The Steritec Cross-Checks P Process Indicator Strips arc similas in design, and function to the: Johnson & Johnson Sterrad Chemical Indicator Sirips Ref 14100 510(k) K921910) Description of Steritec Cross-Checks P process indicator strips: \ j SteriTec Cross-Checks P strips are 4" x §/8” proces- indi…	Johnson & Johnson Medical, Inc.	1993	—

Also cleared against K921910: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 15, 2009	Not classified	Z-1532-2010	Other	This action notifies affected SteriTec customers as well as private label distributors of the necessity to modify the shelf life of their products. There is insufficient data on file to support the shelf life dating on the product labeling.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
4 other devices also cite its predicate K921910.

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?

Cross-Checks P chemical process indicator strips are designed to be used in the Sterrad sterilizer. Cross-Checks P Process Indicator Strips will exhibit a blue to red color change when exposed to hydrogen peroxide during the diffusion phase of the Sterrad cycle. When used as directed, the Cross-Checks P strips give visible confirmation that the item has been exposed to hydrogen peroxide during the Sterrad cycle.

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/K972300 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972300: Cross-Checks P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972300

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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