510(k) · Cleared
ClearedNamsa Steam Self-Contained Biological Indicators
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 Jan 20, 2012 after a 73-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 20, 2012
- Review
- 73 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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.
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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 | Decided |
|---|---|---|---|
| * | — | 3M Attest Product Code 1262/1262P (Pre-amendment) Named without a submission number |
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.
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 SOBI is intended for use in monitoring the efficacy of saturated steam sterilization processes. Performance characteristics are for pre-vacuum and gravity displacement 12100C steam processes. Additional saturated steam sterilization temperatures are also included on the Certificate of Analysis. NAMSA Steam SCBls are also appropriate for use in saturated steam processes of 1320C, 134 C and 135 C. Exposure times at 121 0OC are 30 minutes and 3…
Read the full statement (183 words)
The NAMSA SOBI is intended for use in monitoring the efficacy of saturated steam sterilization processes. Performance characteristics are for pre-vacuum and gravity displacement 12100C steam processes. Additional saturated steam sterilization temperatures are also included on the Certificate of Analysis. NAMSA Steam SCBls are also appropriate for use in saturated steam processes of 1320C, 134 C and 135 C. Exposure times at 121 0OC are 30 minutes and 3 minutes for exposures at 13200, 134CC and 13500. Reference the sterilizer user manual for specific exposure timeframes. The NAMSA Steam SCBls are placed into a sterilization load in a location that has been determined to be the most difficult to sterilize. A sterilization cycle appropriate for the particular type of load is run. The SOBI is removed after the cycle is complete and has cooled to a point where the SCBI can comfortably be handled. The SCBI is activated by pushing the sides with enough force to break the ampoule containing the growth medium. The activated SCBI is incubated at 58-620C for 24 hours. A reduced incubation time of 24 hours has been validated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113302: Namsa Steam Self-Contained Biological Indicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113302
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026