510(k) · Cleared
Recalled · Class III · 20223M 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 Healthcare · QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator
Cleared on Mar 13, 2020 as substantially equivalent to K183211 (3M Company, 2019) after a 122-day review. Its family tree reaches back 5 generations to 1993. 7 later devices descend from it. It has been recalled once.
- Decided
- Mar 13, 2020
- Review
- 122 days
- Class
- Class II
- Product code
- QKM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K921910 (1993). 7 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- 4 generations backK013228 3M Comply 1248 Gas Plasma Chemical IndicatorMinnesota Mining and Mfg. Co. · 2002 · Recalled
- 3 generations backK150622 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2015
- 2 generations backK170321 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2017
- 1 generation backK183211 3M Comply Hydrogen Peroxide Chemical Indicator3M Company · 2019
- This deviceK193110 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator…3M Healthcare · 2020
- Descendant · cites it directly · 6 of its ownK203284 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator3M Company · 2020
- Descendant · 2 generations on · 3 of its ownK213262 CELERITY HP Chemical IndicatorSTERIS Corporation · 2022
- Descendant · 3 generations on · 2 of its ownK231488 Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical…Steris · 2023
- Descendant · 4 generations on · 1 of its ownK240760 CELERITY HP Indicator TapeSteris · 2024
- Descendant · 2 generations on · 1 of its ownK212022 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator…3M Company · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K2032843M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator3M Company · 2020 · cites it directly6descendants
- K213262CELERITY HP Chemical IndicatorSTERIS Corporation · 2022 · 2 generations on3descendants
- K231488Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY…Steris · 2023 · 3 generations on2descendants
- K240760CELERITY HP Indicator TapeSteris · 2024 · 4 generations on1descendant
- K2120223M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E3M Company · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| −4 | K013228 | 3M Comply 1248 Gas Plasma Chemical Indicator | Minnesota Mining and Mfg. Co. | 2002 | 1 |
| −3 | K150622 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2015 | — |
| −2 | K170321 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2017 | — |
| −1 | K183211 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | 2019 | — |
| 0 (this device) | K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Healthcare | 2020 | — |
| +1 | K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator | 3M Company | 2020 | — |
| +2 | K213262 | CELERITY HP Chemical Indicator | STERIS Corporation | 2022 | — |
| +3 | K231488 | Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical… | Steris | 2023 | — |
| +4 | K240760 | CELERITY HP Indicator Tape | Steris | 2024 | — |
| +2 | K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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 K212022 3M Attest Vaporized Hydrogen Peroxide…score 8.0 · 7 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 |
|---|---|---|---|
| * | K183211 | 3M Comply Hydrogen Peroxide Chemical IndicatorSummary page 5…l/chemical sterilization process Device Classification: Class II, 21 CFR § 880.2800 Product Code: QKM 2. Predicate Device: K183211 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 3. Description of Device: The 3M™ Attest™ Vaporized Hydrogen Pe… | 2019 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator | 2020 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class III | Z-1794-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K203284 (3M Company, 2020) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K183211.
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. 2020, 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 hydrogen peroxide sterilization sterilizers and cycles: STERRAD™ 100S System, STERRAD™ NX™ System (Standard and Advanced cycles), STERRAD™ NX™ System with AIIClear™ Technology (Standard and Advanced cycles), STERRAD™ 100NX™ System (Standard, Flex, Express and Duo cycles) STERRAD™ 100NX™ System with AIIClear™ Technology…
Read the full statement (122 words)
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 System, STERRAD™ NX™ System (Standard and Advanced cycles), STERRAD™ NX™ System with AIIClear™ Technology (Standard and Advanced cycles), STERRAD™ 100NX™ System (Standard, Flex, Express and Duo cycles) STERRAD™ 100NX™ System with AIIClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS™ V-PRO™ 1 (Lumen cycle), STERIS™ V-PRO™ 1 Plus (Lumen and Non-Lumen cycles) and STERIS™ V-PRO™ maX Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS™ V-PRO™ 60 Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), and STERIS™ V-PRO™ maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193110: 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/K193110
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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