510(k) · Cleared

Cleared

Spsmedical Sporview Steam BI Test Pack

K022706510(k) TraditionalCleared Oct 25, 200272-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. · FRC Indicator, Biological Sterilization Process

Cleared on Oct 25, 2002 as substantially equivalent to K001444 (Steritec Products, Inc., 2000) after a 72-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.

Decided: Oct 25, 2002
Review: 72 days
Class: Class II
Product code: FRC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001444 (2000). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK001444 Steritec Steam Biological Test Pack with Instant Readout Integrator…Steritec Products, Inc. · 2000 · Recalled
This deviceK022706 Spsmedical Sporview Steam BI Test PackSpsmedical Supply Corp. · 2002
Descendant · cites it directly · 1 of its ownK051173 Spsmedical Sporview Plus Steam BI Test PackSpsmedical Supply Corp. · 2005
Descendant · 2 generations on · 0 of its ownK140620 Sporview Plus BI Test PackCrosstex International · 2014

Most influential descendants

Showing 2 of 2 · See all

K051173Spsmedical Sporview Plus Steam BI Test PackSpsmedical Supply Corp. · 2005 · cites it directly1descendant
K140620Sporview Plus BI Test PackCrosstex International · 2014 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001444	Steritec Steam Biological Test Pack with Instant Readout Integrator, Model BI…	Steritec Products, Inc.	2000	2
0 (this device)	K022706	Spsmedical Sporview Steam BI Test Pack	Spsmedical Supply Corp.	2002	—
+1	K051173	Spsmedical Sporview Plus Steam BI Test Pack	Spsmedical Supply Corp.	2005	—
+2	K140620	Sporview Plus BI Test Pack	Crosstex International	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2014	1	0

FIG. 1 — Lineage of K022706, 2000–2014Source: 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? (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
*	K001444	Steritec Steam Biological Test Pack with Instant Readout Integrator, Model BI 103	Steritec Products, Inc.	2000	2

Also cleared against K001444: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051173	Spsmedical Sporview Plus Steam BI Test Pack	Spsmedical Supply Corp.	2005	1

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 a recall.
Of its descendants, K051173 (Spsmedical Supply Corp., 2005) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K001444.

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?

The SPSmedical SporView Steam BI Test Pack is indicated for use in routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and prevacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022706 · printed Nov 3, 2026

Cite this page

510(k) Report. “K022706: Spsmedical Sporview Steam BI Test Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K022706

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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