510(k) · Cleared

Recalled · Class II · 2013

Eztest-Steam

K930682510(k) TraditionalCleared Apr 4, 1994418-day reviewClass II21 CFR 880.2800Recalls 4

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sgm Biotech, Inc. · FRC Indicator, Biological Sterilization Process

Cleared on Apr 4, 1994 after a 418-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 13 later devices descend from it. It has been recalled 4 times.

Decided: Apr 4, 1994
Review: 418 days
Class: Class II
Product code: FRC
Recalls: 4
Predicates: 0

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

This deviceK930682 Eztest-SteamSgm Biotech, Inc. · 1994
Descendant · cites it directly · 12 of its ownK963841 EztestSgm Biotech, Inc. · 1997 · Recalled
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
Descendant · 2 generations on · 2 of its ownK071895 Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSTERIS Corporation · 2007
Descendant · 2 generations on · 2 of its ownK041386 Raven Protest - SteamRaven Biological Laboratories, Inc. · 2004

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1997high 2 (2007) · low 0 (1998)2026

Most influential descendants

Showing 5 of 13 · See all

K963841EztestSgm Biotech, Inc. · 1997 · cites it directly12descendants
K070595Sporview Steam Self-Contained Biological IndicatorSpsmedical Supply Corp. · 2007 · 2 generations on3descendants
K111515Spsmedical Sporview Steam BISpsmedical Supply Corp. · 2012 · 3 generations on2descendants
K071895Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSTERIS Corporation · 2007 · 2 generations on2descendants
K041386Raven Protest - SteamRaven Biological Laboratories, Inc. · 2004 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K930682	Eztest-Steam	Sgm Biotech, Inc.	1994	—
+1	K963841	Eztest	Sgm Biotech, Inc.	1997	1
+2	K070595	Sporview Steam Self-Contained Biological Indicator	Spsmedical Supply Corp.	2007	—
+3	K111515	Spsmedical Sporview Steam BI	Spsmedical Supply Corp.	2012	—
+2	K071895	Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator	STERIS Corporation	2007	—
+2	K041386	Raven Protest - Steam	Raven Biological Laboratories, Inc.	2004	—

Descendants by year cleared

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

FIG. 1 — Lineage of K930682, 1994–2020Source: 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.

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (13)

See all 13

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
K093794	Smart-Read Eztest-Steam Scbi and Test Pack	Sgm Biotech, Inc.	2010	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 10, 2013	Class II	Z-1824-2013	Nonconforming Material/Component	Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Jun 10, 2013	Class II	Z-1822-2013	Nonconforming Material/Component	Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Jun 10, 2013	Class II	Z-1823-2013	Nonconforming Material/Component	Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Jun 4, 2013	Class II	Z-1867-2013	Nonconforming Material/Component	Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.

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 FRC devices

FRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRC

6in 2025

2007high 18 (2018) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRC

29in 2025

2007high 260 (2013) · low 29 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRC

8so far in 2026, the most since 2007

2007high 8 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FRC

9in 2025

2007high 482 (2016) · low 9 (2022)2025

MAUDE reports naming product code FRC, 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	3	83	0	100
2008	1	—	0	60
2009	6	183	1	45
2010	4	165	0	57
2011	6	118	0	37
2012	9	178	2	46
2013	4	260	2	39
2014	13	174	0	51
2015	3	130	0	182
2016	2	—	0	482
2017	10	130	0	182
2018	18	97	0	22
2019	5	88	0	30
2020	10	150	0	16
2021	5	107	0	10
2022	5	193	4	9
2023	6	190	1	20
2024	8	105	0	22
2025	6	29	0	9
2026	1	—	8	—

https://510kreport.com/device/K930682 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930682: Eztest-Steam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930682

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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