510(k) · Cleared

Cleared

Spsmedical Gas Plasma Chemical Indicator

K030680510(k) TraditionalCleared May 9, 200365-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

Spsmedical Supply Corp. · JOJ Indicator, Physical/Chemical Sterilization Process

Cleared on May 9, 2003 as substantially equivalent to K921910 (Johnson & Johnson Medical, Inc., 1993) after a 65-day review. Its family tree reaches back 1 generation to 1993. 6 later devices descend from it.

Decided: May 9, 2003
Review: 65 days
Class: Class II
Product code: JOJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K921910 (1993). 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
This deviceK030680 Spsmedical Gas Plasma Chemical IndicatorSpsmedical Supply Corp. · 2003
Descendant · cites it directly · 5 of its ownK090650 Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSpsmedical Supply Corp. · 2009
Descendant · cites it directly · 4 of its ownK110152 Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSpsmedical Supply Corp. · 2011
Descendant · 2 generations on · 3 of its ownK140566 Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator TapeCrosstex International · 2014
Descendant · 3 generations on · 0 of its ownK200096 Crosstex VH2O2 Chemical IndicatorsCrosstex International, Inc. (A Cantel Medical Company) · 2021
Descendant · 2 generations on · 0 of its ownK191999 Sterilucent VH2O2 Chemical IndicatorsSterilucent, Inc. · 2019

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2009high 1 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · See all

K090650Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSpsmedical Supply Corp. · 2009 · cites it directly5descendants
K110152Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSpsmedical Supply Corp. · 2011 · cites it directly4descendants
K140566Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator TapeCrosstex International · 2014 · 2 generations on3descendants
K200096Crosstex VH2O2 Chemical IndicatorsCrosstex International, Inc. (A Cantel Medical Company) · 2021 · 3 generations on0descendants
K191999Sterilucent VH2O2 Chemical IndicatorsSterilucent, Inc. · 2019 · 2 generations on0descendants

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)	K030680	Spsmedical Gas Plasma Chemical Indicator	Spsmedical Supply Corp.	2003	—
+1	K090650	Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators	Spsmedical Supply Corp.	2009	—
+1	K110152	Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators	Spsmedical Supply Corp.	2011	—
+2	K140566	Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator Tape	Crosstex International	2014	—
+3	K200096	Crosstex VH2O2 Chemical Indicators	Crosstex International, Inc. (A Cantel Medical Company)	2021	—
+2	K191999	Sterilucent VH2O2 Chemical Indicators	Sterilucent, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2011	1	0
2014	1	0
2015	1	0
2019	1	0
2021	1	0

FIG. 1 — Lineage of K030680, 1993–2021Source: 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
*	K921910	Sterrad Chemical Indicator Summary page 1 …SOJOJ Prediats Device: Advanced Sterll-kation Products (ASP) Gas Plasma jndlcator Ship (K921910). me SPSmed{calGas Plasma Chemicallodioatorsare process hdimbn used to v e ~ exposwe to vapor hydrogen pe…	Johnson & Johnson Medical, Inc.	1993	—

Also cleared against K921910: 4 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K090650	Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators	Spsmedical Supply Corp.	2009	5
K110152	Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators	Spsmedical Supply Corp.	2011	4

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?

Its one ancestor has no recall.
Of its descendants, K090650 (Spsmedical Supply Corp., 2009) has gone furthest, with 5 descendants of its own.
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?

The SPSmedical Gas Plasma Chemical Indicators are indicated for use as process indicators to verify exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S and STERRAD® 50 sterilization processes. They are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed item. Indicators change to a signal color of BLUE after exposure to vapor hydrogen peroxide in these sterilization processes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030680 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030680: Spsmedical Gas Plasma Chemical Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030680

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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