510(k) · Cleared
Recalled · Class II · 2024Spsmedical Sporview Bacterial Spore Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spsmedical Supply Corp. · FRC Indicator, Biological Sterilization Process
Cleared on Dec 5, 2002 as substantially equivalent to K905425 (Spsmedical Supply Corp., 1992) after a 30-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 5, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- FRC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905425 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK905425 SporviewSpsmedical Supply Corp. · 1992 · Recalled
- This deviceK023716 Spsmedical Sporview Bacterial Spore StripSpsmedical Supply Corp. · 2002
- Descendant · cites it directly · 0 of its ownK041099 Modification to Spsmedical Sporview Bacterial Spore StripSpsmedical Supply Corp. · 2004 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K041099Modification to Spsmedical Sporview Bacterial Spore StripSpsmedical Supply Corp. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905425 | Sporview | Spsmedical Supply Corp. | 1992 | 2 |
| 0 (this device) | K023716 | Spsmedical Sporview Bacterial Spore Strip | Spsmedical Supply Corp. | 2002 | — |
| +1 | K041099 | Modification to Spsmedical Sporview Bacterial Spore Strip | Spsmedical Supply Corp. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K905425 | SporviewSummary page 1…evice Classification: Class II, Regulation Number 880.2800 Product Code: FRC Predicate Device: SPSmedical SporViewB Bacterial Spore Strip (K905425) Device Description: The SPSmedical SporViewB Bacterial Spore Strip is a .250’ x 1 1/2“ Whatman 3MM chromatograph… | 1992 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041099 | Modification to Spsmedical Sporview Bacterial Spore Strip | 2004 | 0 |
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?
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRC
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRC
8so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRC
9in 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 SporViewQ Bacterial Spore Strip is designed to monitor steam sterilizer cycles at 121°C and 132°C. The combination of SPSmedical’s spore strip and SporViewB Culture Media (Tryptic Soy Broth, Modified with Bromocresol Purple) has been validated at 60°C for a reduced incubation time of 24 hours for steam sterilization processes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023716: Spsmedical Sporview Bacterial Spore Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023716
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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