510(k) · Cleared
Recalled · Class II · 2026Modification to Raven Bacterial Spore Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Raven Biological Laboratories, Inc. · FRC Indicator, Biological Sterilization Process
Cleared on Mar 23, 2005 after a 15-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 23, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- FRC
- Recalls
- 2
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK050591 Modification to Raven Bacterial Spore StripsRaven Biological Laboratories, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK141244 Namsa Biological Indicator Spore Strips (Dual Species) Namsa…North American Science Assoc., Inc. · 2014
- Descendant · cites it directly · 0 of its ownK113221 Namsa Biological Indicator Spore StripsNorth American Science Assoc., Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050591 | Modification to Raven Bacterial Spore Strips | Raven Biological Laboratories, Inc. | 2005 | — |
| +1 | K141244 | Namsa Biological Indicator Spore Strips (Dual Species) Namsa Biological… | North American Science Assoc., Inc. | 2014 | — |
| +1 | K113221 | Namsa Biological Indicator Spore Strips | North American Science Assoc., Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 13, 2026 | Class II | Z-2331-2026 | Under Investigation by firm | Due to incorrect incubation process being performed on product. |
| Apr 13, 2026 | Class II | Z-2332-2026 | Under Investigation by firm | Due to incorrect incubation process being performed on product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K141244 (North American Science Assoc., Inc., 2014) has gone furthest, with 0 descendants of its own.
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 Raven Bacterial Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilusATCC #7953 and B. atrophaeusATCC #9372) is intended for use in testing the efficacy of Chemiclave sterilization cycles at 132 0C. A reduced incubation time of 72 hours at 600C +/- 20C has been validated for Chemiclave sterilization when the Raven Bacterial Spore Strip (either the single species G. stearothermophilusspore strip or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050591 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050591: Modification to Raven Bacterial Spore Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050591
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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