510(k) · Cleared
ClearedNamsa Biological Indicator Spore Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North American Science Assoc., Inc. · FRC Indicator, Biological Sterilization Process
Cleared on Apr 27, 2012 as substantially equivalent to K912796 (Raven Biological Laboratories, Inc., 1992) and 2 other predicates after a 178-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Apr 27, 2012
- Review
- 178 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K912796 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK912796 Spore StripRaven Biological Laboratories, Inc. · 1992
- This deviceK113221 Namsa Biological Indicator Spore StripsNorth American Science Assoc., Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912796 | Spore Strip | Raven Biological Laboratories, Inc. | 1992 | — |
| 0 (this device) | K113221 | Namsa Biological Indicator Spore Strips | North American Science Assoc., Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 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? (3)
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 |
|---|---|---|---|
| * | K912796 | Spore StripSummary page 1…FDA Product Code FRC, General Hospital Predicate Devices: NAMSA Biological Indicator Spore Strips (Legally Marketed) Predicate Device 510(k) Number: K(912796, K(020026 and K(050591 Description: The NAMSA Biological Indicator Spore Strip consists of a 1.25" x 0.25" filter p… | 1992 |
| * | K020026 | Raven Bacterial Spore StripsSummary page 1…t Code FRC, General Hospital Predicate Devices: NAMSA Biological Indicator Spore Strips (Legally Marketed) Predicate Device 510(k) Number: K(912796, K(020026 and K(050591 Description: The NAMSA Biological Indicator Spore Strip consists of a 1.25" x 0.25" filter papl.er str… | 2002 |
| * | K050591 | Modification to Raven Bacterial Spore StripsSummary page 1…eneral Hospital Predicate Devices: NAMSA Biological Indicator Spore Strips (Legally Marketed) Predicate Device 510(k) Number: K(912796, K(020026 and K(050591 Description: The NAMSA Biological Indicator Spore Strip consists of a 1.25" x 0.25" filter papl.er strip… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K912796.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCCO 7953, or dual species Geobacillus steamthermophilus ATCCO 7953 and Bacillus atmophaeus ATCCe 9372). is intended for use in testing the efficacy of steam sterilization for single species and steam and ethylene oxide sterilization for dual species. Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138 and USP for 1210 C steam gravity…
Read the full statement (114 words)
The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCCO 7953, or dual species Geobacillus steamthermophilus ATCCO 7953 and Bacillus atmophaeus ATCCe 9372). is intended for use in testing the efficacy of steam sterilization for single species and steam and ethylene oxide sterilization for dual species. Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138 and USP for 1210 C steam gravity displacement for 30 minutes and ethylene oxide at 600 mg/L, 60% RH and 550C for 2 hours, 10 minutes. A reduced incubation time of 24 hours for steam sterilization has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113221: Namsa Biological Indicator Spore Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113221
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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