510(k) · Cleared

Cleared

Eztest-Gas

K930683510(k) TraditionalCleared Mar 4, 19971,483-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

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

Cleared on Mar 4, 1997 as substantially equivalent to K895704 (Pymah Corp., Ati Div., 1990) and 2 other predicates after a 1,483-day review. Its family tree reaches back 1 generation to 1980. 5 later devices descend from it.

Decided: Mar 4, 1997
Review: 1,483 days
Class: Class II
Product code: FRC
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K801109 (1980). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK801109 Proof (Biological/Chemical Indicator)Amsco Co. · 1980
This deviceK930683 Eztest-GasSgm Biomedical, Inc. · 1997
Descendant · cites it directly · 3 of its ownK151585 Andersen EOGas 4 SteriTestAndersen Sterilizers, Inc. · 2015
Descendant · 2 generations on · 0 of its ownK202879 EOGas 4 Endo-SteriTest RRBIAndersen Sterilizers, Inc. · 2021
Descendant · 2 generations on · 0 of its ownK192980 EOGas 4 Endo-SteriTestAndersen Sterilizers, Inc. · 2020
Descendant · 2 generations on · 0 of its ownK170427 Anprolene SteriTestAndersen Sterilizers, Inc. · 2017
Descendant · cites it directly · 0 of its ownK041784 Raven Protest - EORaven Biological Laboratories, Inc. · 2004

Most influential descendants

Showing 5 of 5 · See all

K151585Andersen EOGas 4 SteriTestAndersen Sterilizers, Inc. · 2015 · cites it directly3descendants
K202879EOGas 4 Endo-SteriTest RRBIAndersen Sterilizers, Inc. · 2021 · 2 generations on0descendants
K192980EOGas 4 Endo-SteriTestAndersen Sterilizers, Inc. · 2020 · 2 generations on0descendants
K170427Anprolene SteriTestAndersen Sterilizers, Inc. · 2017 · 2 generations on0descendants
K041784Raven Protest - EORaven Biological Laboratories, Inc. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K801109	Proof (Biological/Chemical Indicator)	Amsco Co.	1980	—
0 (this device)	K930683	Eztest-Gas	Sgm Biomedical, Inc.	1997	—
+1	K151585	Andersen EOGas 4 SteriTest	Andersen Sterilizers, Inc.	2015	—
+2	K202879	EOGas 4 Endo-SteriTest RRBI	Andersen Sterilizers, Inc.	2021	—
+2	K192980	EOGas 4 Endo-SteriTest	Andersen Sterilizers, Inc.	2020	—
+2	K170427	Anprolene SteriTest	Andersen Sterilizers, Inc.	2017	—
+1	K041784	Raven Protest - EO	Raven Biological Laboratories, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2015	1	0
2017	1	0
2020	1	0
2021	1	0

FIG. 1 — Lineage of K930683, 1980–2021Source: 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 FRC? 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 FRC device

#1 K250044 Celerity 5 HP Biological Indicator (LCB052)…score 14.5 · 10 generations · no Class I recall
#2 Held for the reportin the report
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What was it cleared against? (4)

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
*	K895704	Ati Disp. Biological Test Pack for Ethylene Oxide Summary page 3 …hylene oxide gas [as required by Section 807.92(a)(2)] 5-2 SUBSTANTIALLY EQUIVALENT TO THE FOLLOWING LEGALLY MARKETED DEVICES: ATITEST® - PyMaH Corp. (K895704) ATTEST® - 3M Co. (pre 1976 device) PROOF® - AMSCO (K801109) [as required by Section 807.92(a)(3)] DESCRIPTION OF DEVICE: EZTes…	Pymah Corp., Ati Div.	1990	—
*	K801109	Proof (Biological/Chemical Indicator) Summary page 3 …SUBSTANTIALLY EQUIVALENT TO THE FOLLOWING LEGALLY MARKETED DEVICES: ATITEST® - PyMaH Corp. (K895704) ATTEST® - 3M Co. (pre 1976 device) PROOF® - AMSCO (K801109) [as required by Section 807.92(a)(3)] DESCRIPTION OF DEVICE: EZTest® - Gas [as required by Section 807.92(a)(4)] The biologi…	Amsco Co.	1980	—
*	K902344	Ati Disposable Biological Test Pack for Steam Ster Summary page 6 …provided of the legally marketed predicate devices describing similarities and differences such as technology and other important characteristics. A ATITest® PyMaH/ATI (K902344): This device is exactly the same as the PyMaH ATITest® disclosed in 510(k) notification K902344. The ATITest® was developed by…	Ati	1990	—
*	—	Attest® Named without a submission number			—

Also cleared against K895704: 1 other device →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K151585	Andersen EOGas 4 SteriTest	Andersen Sterilizers, Inc.	2015	3
K041784	Raven Protest - EO	Raven Biological Laboratories, Inc.	2004	0

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?

None of the 3 ancestors has a recall.
Of its descendants, K151585 (Andersen Sterilizers, Inc., 2015) has gone furthest, with 3 descendants of its own.
1 other device also cites its predicate K895704.

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	—

What is it indicated for?

EZTest® - Gas self contained biological indicators are for monitoring the efficacy of ethylene oxide gas sterilization processors. Performance characteristics are established in accordance with USP XXIil for the 600mg/l process.

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/K930683 · printed Nov 3, 2026

Cite this page

510(k) Report. “K930683: Eztest-Gas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K930683

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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