510(k) · Cleared

Recalled · Class II · 2024

Modification to Spsmedical Sporview Bacterial Spore Strip

K041099510(k) SpecialCleared May 6, 200410-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

Spsmedical Supply Corp. · FRC Indicator, Biological Sterilization Process

Cleared on May 6, 2004 as substantially equivalent to K023716 (Spsmedical Supply Corp., 2002) and 1 other predicate after a 10-day review. Its family tree reaches back 2 generations to 1992. It has been recalled once.

Decided: May 6, 2004
Review: 10 days
Class: Class II
Product code: FRC
Recalls: 1
Predicates: 2

Its longest line of descent runs back 2 generations to K905425 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK905425 SporviewSpsmedical Supply Corp. · 1992 · Recalled
1 generation backK023716 Spsmedical Sporview Bacterial Spore StripSpsmedical Supply Corp. · 2002 · Recalled
This deviceK041099 Modification to Spsmedical Sporview Bacterial Spore StripSpsmedical Supply Corp. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K905425	Sporview	Spsmedical Supply Corp.	1992	2
−1	K023716	Spsmedical Sporview Bacterial Spore Strip	Spsmedical Supply Corp.	2002	1
0 (this device)	K041099	Modification to Spsmedical Sporview Bacterial Spore Strip	Spsmedical Supply Corp.	2004	—

FIG. 1 — Lineage of K041099, 1992–2004Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K023716	Spsmedical Sporview Bacterial Spore Strip Summary page 1 …ssification: Class II, Regulation Number 880.2800 Product Code: FRC Predicate Device: SPSmedical SporView* Bacterial Spore Strip K023716 & K905425 8 Device Description: The SPS…	Spsmedical Supply Corp.	2002	1
*	K905425	Sporview Summary page 1 …n Number 880.2800 Product Code: FRC Predicate Device: SPSmedical SporView* Bacterial Spore Strip K023716 & K905425 8 Device Description: The SPSmedical SporView® Bacterial Spore Strip i…	Spsmedical Supply Corp.	1992	2

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 11, 2024	Class II	Z-1141-2025	Error in labeling	Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 10.7 years on median.
2 of the 2 ancestors have a recall of any class.

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® Bacterial Spore Strip is designed to monitor Chemiclave® chemical vapor sterilizers. The combination of SPSmedical's spore strip and SporView® Culture Media (Tryptic Soy Broth, Modified with Bromocresol Purple) has been validated at 60°C for a reduced incubation time of 72 hours for the Chemiclave® chemical vapor sterilization process.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041099 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041099: Modification to Spsmedical Sporview Bacterial Spore Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041099

Report an extraction error

Are you the manufacturer?

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