510(k) · Cleared

Recalled · Class II · 2013

Eztest

K963841510(k) TraditionalCleared Feb 25, 1997153-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

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

Cleared on Feb 25, 1997 as substantially equivalent to K930682 (Sgm Biotech, Inc., 1994) and 2 other predicates after a 153-day review. Its family tree reaches back 1 generation to 1980. 12 later devices descend from it. It has been recalled once.

Decided: Feb 25, 1997
Review: 153 days
Class: Class II
Product code: FRC
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K801109 (1980). 3 ancestors in all. 12 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK801109 Proof (Biological/Chemical Indicator)Amsco Co. · 1980
This deviceK963841 EztestSgm Biotech, Inc. · 1997
Descendant · cites it directly · 3 of its ownK070595 Sporview Steam Self-Contained Biological IndicatorSpsmedical Supply Corp. · 2007
Descendant · 2 generations on · 2 of its ownK111515 Spsmedical Sporview Steam BISpsmedical Supply Corp. · 2012
Descendant · cites it directly · 2 of its ownK071895 Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSTERIS Corporation · 2007
Descendant · cites it directly · 2 of its ownK041386 Raven Protest - SteamRaven Biological Laboratories, Inc. · 2004
Descendant · 2 generations on · 1 of its ownK122024 Spsmedical Sporview 10 Steam Self Contained Biological IndicatorSpsmedical Supply Corp. · 2013

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2004high 2 (2007) · low 0 (2005)2026

Most influential descendants

Showing 5 of 12 · See all

K070595Sporview Steam Self-Contained Biological IndicatorSpsmedical Supply Corp. · 2007 · cites it directly3descendants
K111515Spsmedical Sporview Steam BISpsmedical Supply Corp. · 2012 · 2 generations on2descendants
K071895Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSTERIS Corporation · 2007 · cites it directly2descendants
K041386Raven Protest - SteamRaven Biological Laboratories, Inc. · 2004 · cites it directly2descendants
K122024Spsmedical Sporview 10 Steam Self Contained Biological IndicatorSpsmedical Supply Corp. · 2013 · 2 generations on1descendant

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)	K963841	Eztest	Sgm Biotech, Inc.	1997	—
+1	K070595	Sporview Steam Self-Contained Biological Indicator	Spsmedical Supply Corp.	2007	—
+2	K111515	Spsmedical Sporview Steam BI	Spsmedical Supply Corp.	2012	—
+1	K071895	Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator	STERIS Corporation	2007	—
+1	K041386	Raven Protest - Steam	Raven Biological Laboratories, Inc.	2004	—
+2	K122024	Spsmedical Sporview 10 Steam Self Contained Biological Indicator	Spsmedical Supply Corp.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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 K963841, 1980–2020Source: 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
#3 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
*	K930682	Eztest-Steam Summary page 2 …r steam [as required by Section 807.92(a)(2)] 11-2 27 SUBSTANTIALLY EQUIVALENT TO THE FOLLOWING LEGALLY MARKETED DEVICES: EZTest® - SGM Biotech, Inc. (K930682) ATITEST® - PyMaH Corp. (KS02344) ATTEST® - 3M Co. (pre 1976 device) PROOF® - AMSCO (K801109) [as required by Section 807.92(a)(…	Sgm Biotech, Inc.	1994	4
*	K902344	Ati Disposable Biological Test Pack for Steam Ster Summary page 5 …this device. The difference is the extension of the label claims for use in high temperature saturated steam processes of 132°C, 134°C and 135°C. B. ATITest® PyMaH/ATI (K902344): This device is exactly the same as the PyMaH ATITest® disclosed in 510(k) notification K302344. The ATITest® was developed by…	Ati	1990	—
*	K801109	Proof (Biological/Chemical Indicator) Summary page 2 …ENT TO THE FOLLOWING LEGALLY MARKETED DEVICES: EZTest® - SGM Biotech, Inc. (K930682) ATITEST® - PyMaH Corp. (KS02344) ATTEST® - 3M Co. (pre 1976 device) PROOF® - AMSCO (K801109) [as required by Section 807.92(a)(3)] DESCRIPTION OF DEVICE: EZTest® - Steam [as required by Section 807.92(a)(4)] The biolo…	Amsco Co.	1980	—
*	—	Attest® Named without a submission number			—

Also cleared against K930682: 1 other device →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K070595	Sporview Steam Self-Contained Biological Indicator	Spsmedical Supply Corp.	2007	3
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	2
K093794	Smart-Read Eztest-Steam Scbi and Test Pack	Sgm Biotech, Inc.	2010	1
K083665	Verify Scbi 275F 3-10	STERIS Corporation	2009	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K070595 (Spsmedical Supply Corp., 2007) has gone furthest, with 3 descendants of its own.
1 other device also cites its predicate K930682.

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® - Steam self contained biological indicators are for monitoring the efficacy of saturated steam sterilization processors. Performance characteristics are established in accordance with USP XXiil for the 121 C - steam process. Additional saturated steam sterilization conditions are also included in the Certificate of Performance. EZTest® - Steam Bls are also appropriate for use in the high temperature saturated steam processes of 132C, 134 C and 135C.

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/K963841 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963841: Eztest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963841

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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