510(k) · Cleared
Cleared3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · FRC Indicator, Biological Sterilization Process
Cleared on Jun 27, 2024 as substantially equivalent to K211705 (3M Company, 2022) and 1 other predicate after a 104-day review. Its family tree reaches back 14 generations to 2002.
- Decided
- Jun 27, 2024
- Review
- 104 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K994055 (2002). 29 ancestors in all, the oldest K900771 (1990). No later device cites it as a predicate yet.
- Root · 14 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
- 10 generations between
- 3 generations backK200996 3M Attest Rapid Readout Biological Indicator3M Company · 2020
- 2 generations backK210277 3M Attest Rapid Readout Biological Indicator, 12953M Company · 2021
- 1 generation backK211705 3M Attest Rapid Readout Biological Indicator, 12953M Company · 2022
- This deviceK240717 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™…3M Company · 2024
Show all 14 generations
- Root · 14 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
- 13 generations backK031226 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2003 · Recalled
- 12 generations backK071014 Modification to Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2007
- 11 generations backK102884 Sterrad Cyclesure 24 Biological IndicatorAdvanced Sterilization Products · 2011
- 10 generations backK111375 Sterrad (R) Cyclesure (R) 24 Biological IndicatorAdvanced Sterilization Products · 2012
- 9 generations backK123017 Sterrad Cyclesure 24 Biological Indicator Model 14324Advanced Sterilization Products · 2012
- 8 generations backK140392 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company · 2014
- 7 generations backK152060 3M Attest Rapid Readout Biological Indicator 12953M Company · 2015
- 6 generations backK160546 3M Attest Rapid Readout Biological Indicator3M Company · 2016
- 5 generations backK171003 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader3M Company · 2017
- 4 generations backK173435 3M Attest Rapid Readout Biological Indicator3M Company · 2018
- 3 generations backK200996 3M Attest Rapid Readout Biological Indicator3M Company · 2020
- 2 generations backK210277 3M Attest Rapid Readout Biological Indicator, 12953M Company · 2021
- 1 generation backK211705 3M Attest Rapid Readout Biological Indicator, 12953M Company · 2022
- This deviceK240717 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™…3M Company · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K994055 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2002 | 1 |
| −13 | K031226 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2003 | 1 |
| −12 | K071014 | Modification to Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2007 | — |
| −11 | K102884 | Sterrad Cyclesure 24 Biological Indicator | Advanced Sterilization Products | 2011 | — |
| −10 | K111375 | Sterrad (R) Cyclesure (R) 24 Biological Indicator | Advanced Sterilization Products | 2012 | — |
| −9 | K123017 | Sterrad Cyclesure 24 Biological Indicator Model 14324 | Advanced Sterilization Products | 2012 | — |
| −8 | K140392 | 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader | 3M Company | 2014 | — |
| −7 | K152060 | 3M Attest Rapid Readout Biological Indicator 1295 | 3M Company | 2015 | — |
| −6 | K160546 | 3M Attest Rapid Readout Biological Indicator | 3M Company | 2016 | — |
| −5 | K171003 | 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader | 3M Company | 2017 | — |
| −4 | K173435 | 3M Attest Rapid Readout Biological Indicator | 3M Company | 2018 | — |
| −3 | K200996 | 3M Attest Rapid Readout Biological Indicator | 3M Company | 2020 | — |
| −2 | K210277 | 3M Attest Rapid Readout Biological Indicator, 1295 | 3M Company | 2021 | — |
| −1 | K211705 | 3M Attest Rapid Readout Biological Indicator, 1295 | 3M Company | 2022 | — |
| 0 (this device) | K240717 | 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized… | 3M Company | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2002 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 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? (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 | Decided |
|---|---|---|---|
| * | K211705 | 3M Attest Rapid Readout Biological Indicator, 1295Summary page 7…/chemical sterilization process Device Classification: Class II, 21 CFR § 880.2800 Product Code: QKM 2. Predicate Device: K211705, 3M™ Attest™ Rapid Readout Biological Indicator 1295 K212022, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical… | 2022 |
| * | K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348ESummary page 7…Class II, 21 CFR § 880.2800 Product Code: QKM 2. Predicate Device: K211705, 3M™ Attest™ Rapid Readout Biological Indicator 1295 K212022, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E 3. Description of Device: 3M™… | 2022 |
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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 29 ancestors have a recall of any class.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Use the 3M ™ Attest ™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M ™ Attest ™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: STERRAD 100S® Sterilization System STERRAD NX® Sterilization System (Standard and Advanced cycles) STERRAD 100NX® Sterilization System…
Read the full statement (330 words)
Use the 3M ™ Attest ™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M ™
Attest ™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M
Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization
processes in the following systems:
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and
Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non
Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles)
STERIZONE® VP4 Sterilizer (Cycle 1)
SteroScope® Sterilization System
Use the 3M ™ Attest ™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for
pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles:
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and
Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non
Lumen cycles)
V-PRO® s2 LLow Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles)
STERIZONE® VP4 Sterilizer (Cycle 1)
SteroScope® Sterilization System
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240717 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240717: 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240717
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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