510(k) · Cleared
Cleared3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
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 Dec 7, 2020 as substantially equivalent to K193110 (3M Healthcare, 2020) after a 28-day review. Its family tree reaches back 6 generations to 1993. 6 later devices descend from it.
- Decided
- Dec 7, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- QKM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K921910 (1993). 6 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- 5 generations backK013228 3M Comply 1248 Gas Plasma Chemical IndicatorMinnesota Mining and Mfg. Co. · 2002 · Recalled
- 4 generations backK150622 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2015
- 3 generations backK170321 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2017
- 2 generations backK183211 3M Comply Hydrogen Peroxide Chemical Indicator3M Company · 2019
- 1 generation backK193110 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator…3M Healthcare · 2020 · Recalled
- This deviceK203284 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator3M Company · 2020
- Descendant · cites it directly · 3 of its ownK213262 CELERITY HP Chemical IndicatorSTERIS Corporation · 2022
- Descendant · 2 generations on · 2 of its ownK231488 Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical…Steris · 2023
- Descendant · 3 generations on · 1 of its ownK240760 CELERITY HP Indicator TapeSteris · 2024
- Descendant · cites it directly · 1 of its ownK212022 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator…3M Company · 2022
- Descendant · 4 generations on · 0 of its ownK242189 CELERITY HP Indicator Tape (PCC077)Steris · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K213262CELERITY HP Chemical IndicatorSTERIS Corporation · 2022 · cites it directly3descendants
- K231488Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY…Steris · 2023 · 2 generations on2descendants
- K240760CELERITY HP Indicator TapeSteris · 2024 · 3 generations on1descendant
- K2120223M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E3M Company · 2022 · cites it directly1descendant
- K242189CELERITY HP Indicator Tape (PCC077)Steris · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| −5 | K013228 | 3M Comply 1248 Gas Plasma Chemical Indicator | Minnesota Mining and Mfg. Co. | 2002 | 1 |
| −4 | K150622 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2015 | — |
| −3 | K170321 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2017 | — |
| −2 | K183211 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | 2019 | — |
| −1 | K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Healthcare | 2020 | 1 |
| 0 (this device) | K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator | 3M Company | 2020 | — |
| +1 | K213262 | CELERITY HP Chemical Indicator | STERIS Corporation | 2022 | — |
| +2 | K231488 | Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical… | Steris | 2023 | — |
| +3 | K240760 | CELERITY HP Indicator Tape | Steris | 2024 | — |
| +1 | K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company | 2022 | — |
| +4 | K242189 | CELERITY HP Indicator Tape (PCC077) | Steris | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348ESummary page 5…l/chemical sterilization process Device Classification: Class II, 21 CFR § 880.2800 Product Code: QKM 2. Predicate Device: K193110, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E 3. Description of Device: The… | 2020 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K213262 (STERIS Corporation, 2022) has gone furthest, with 3 descendants of its own.
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 AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX® System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ Technology…
Read the full statement (138 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 AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX® System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ 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), STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles), and the STERIS® V-PRO® s2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast cycles).
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/K203284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203284: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203284
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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