510(k) · Cleared

Cleared

Proof (Biological/Chemical Indicator)

K801109510(k) TraditionalCleared May 30, 198018-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

Amsco Co. · JOJ Indicator, Physical/Chemical Sterilization Process

Cleared on May 30, 1980 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.

Decided: May 30, 1980
Review: 18 days
Class: Class II
Product code: JOJ
Recalls: None
Predicates: 0

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

This deviceK801109 Proof (Biological/Chemical Indicator)Amsco Co. · 1980
Descendant · cites it directly · 12 of its ownK963841 EztestSgm Biotech, Inc. · 1997 · Recalled
Descendant · cites it directly · 5 of its ownK930683 Eztest-GasSgm Biomedical, Inc. · 1997
Descendant · 2 generations on · 3 of its ownK151585 Andersen EOGas 4 SteriTestAndersen Sterilizers, Inc. · 2015
Descendant · 2 generations on · 3 of its ownK070595 Sporview Steam Self-Contained Biological IndicatorSpsmedical Supply Corp. · 2007
Descendant · 3 generations on · 2 of its ownK111515 Spsmedical Sporview Steam BISpsmedical Supply Corp. · 2012

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

1997high 2 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 19 · See all

K963841EztestSgm Biotech, Inc. · 1997 · cites it directly12descendants
K930683Eztest-GasSgm Biomedical, Inc. · 1997 · cites it directly5descendants
K151585Andersen EOGas 4 SteriTestAndersen Sterilizers, Inc. · 2015 · 2 generations on3descendants
K070595Sporview Steam Self-Contained Biological IndicatorSpsmedical Supply Corp. · 2007 · 2 generations on3descendants
K111515Spsmedical Sporview Steam BISpsmedical Supply Corp. · 2012 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K801109	Proof (Biological/Chemical Indicator)	Amsco Co.	1980	—
+1	K963841	Eztest	Sgm Biotech, Inc.	1997	1
+1	K930683	Eztest-Gas	Sgm Biomedical, Inc.	1997	—
+2	K151585	Andersen EOGas 4 SteriTest	Andersen Sterilizers, Inc.	2015	—
+2	K070595	Sporview Steam Self-Contained Biological Indicator	Spsmedical Supply Corp.	2007	—
+3	K111515	Spsmedical Sporview Steam BI	Spsmedical Supply Corp.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
2004	2	0
2007	2	0
2009	2	0
2010	1	0
2011	1	0
2012	2	0
2013	1	0
2015	1	0
2017	2	0
2020	2	0
2021	1	0

FIG. 1 — Lineage of K801109, 1980–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K963841	Eztest	Sgm Biotech, Inc.	1997	12
K930683	Eztest-Gas	Sgm Biomedical, Inc.	1997	5

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, K963841 (Sgm Biotech, Inc., 1997) has gone furthest, with 12 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	—

https://510kreport.com/device/K801109 · printed Nov 5, 2026

Cite this page

510(k) Report. “K801109: Proof (Biological/Chemical Indicator).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K801109

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026