510(k) · Cleared
Cleared3M 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 · QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator
Cleared on Apr 20, 2022 as substantially equivalent to K203284 (3M Company, 2020) after a 295-day review. Its family tree reaches back 7 generations to 1993. 1 later device descends from it.
- Decided
- Apr 20, 2022
- Review
- 295 days
- Class
- Class II
- Product code
- QKM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K921910 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- 6 generations backK013228 3M Comply 1248 Gas Plasma Chemical IndicatorMinnesota Mining and Mfg. Co. · 2002 · Recalled
- 5 generations backK150622 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2015
- 4 generations backK170321 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2017
- 3 generations backK183211 3M Comply Hydrogen Peroxide Chemical Indicator3M Company · 2019
- 2 generations backK193110 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator…3M Healthcare · 2020 · Recalled
- 1 generation backK203284 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator3M Company · 2020
- This deviceK212022 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator…3M Company · 2022
- Descendant · cites it directly · 0 of its ownK240717 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™…3M Company · 2024
Most influential descendants
Showing 1 of 1 · See all- K2407173M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen…3M Company · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| −6 | K013228 | 3M Comply 1248 Gas Plasma Chemical Indicator | Minnesota Mining and Mfg. Co. | 2002 | 1 |
| −5 | K150622 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2015 | — |
| −4 | K170321 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2017 | — |
| −3 | K183211 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | 2019 | — |
| −2 | K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Healthcare | 2020 | 1 |
| −1 | K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator | 3M Company | 2020 | — |
| 0 (this device) | K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company | 2022 | — |
| +1 | K240717 | 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized… | 3M Company | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 QKM? 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 QKM device
- #1 K203284 3M Attest Vaporized Hydrogen Peroxide…score 8.0 · 6 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 |
|---|---|---|---|
| * | K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical IndicatorSummary page 5…l/chemical sterilization process Device Classification: Class II, 21 CFR § 880.2800 Product Code: QKM 1. Predicate Device: K203284, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E 2. Description of Device: The… | 2020 |
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 |
|---|---|---|---|
| K240717 | 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen… | 2024 | 0 |
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 29 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K240717 (3M Company, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K203284.
How does its category compare?
All QKM devicesQKM A Chemical Vapor Sterilization Multivariable Chemical Indicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QKM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QKM
Too few QKM 510(k)s in any year since 2007 to give a median.
Recalls per year · QKM
No recall names QKM since 2007.
Adverse event reports per year · QKM
No MAUDE report names QKM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following 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…
Read the full statement (157 words)
Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following 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 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles)
- STERIZONE® VP4 Sterilizer (Cycle 1)
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/K212022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212022: 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 6, 2026. https://510kreport.com/device/K212022
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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