510(k) · Cleared
ClearedConFirm 20 Minute Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FRC Indicator, Biological Sterilization Process
Cleared on Dec 15, 2023 as substantially equivalent to K223715 (STERIS Corporation, 2023) after a 29-day review. Its family tree reaches back 6 generations to 2002.
- Decided
- Dec 15, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K004009 (2002). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK004009 3M Attest 290 Auto-Reader3M Company · 2002
- 5 generations backK123546 3M Attest (TM) Auto-Reader3M Company · 2013 · Recalled
- 4 generations backK171587 VERIFY Incubator for Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017
- 3 generations backK190297 Celerity HP IncubatorSTERIS Corporation · 2019
- 2 generations backK213881 Celerity IncubatorSTERIS Corporation · 2022
- 1 generation backK223715 Celerity IncubatorSTERIS Corporation · 2023
- This deviceK233681 ConFirm 20 Minute IncubatorSTERIS Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K004009 | 3M Attest 290 Auto-Reader | 3M Company | 2002 | — |
| −5 | K123546 | 3M Attest (TM) Auto-Reader | 3M Company | 2013 | 1 |
| −4 | K171587 | VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | 2017 | — |
| −3 | K190297 | Celerity HP Incubator | STERIS Corporation | 2019 | — |
| −2 | K213881 | Celerity Incubator | STERIS Corporation | 2022 | — |
| −1 | K223715 | Celerity Incubator | STERIS Corporation | 2023 | — |
| 0 (this device) | K233681 | ConFirm 20 Minute Incubator | STERIS Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (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 |
|---|---|---|---|
| * | K223715 | Celerity IncubatorSummary page 6…Hospital and Personal Use Devices Panel Classification Number: 21 CFR 880.2800 Product Code FRC 2. Predicate Device K223715 – Celerity Incubator Reference Device K173634 – ConFirm Biological Indicator (cleared as CELERITY 20 Steam B… | 2023 |
| † | K173634 | CELERITY 20 Steam Biological Indicator | 2018 |
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 21 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K223715.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 ConFirm 20 Minute Incubator to incubate and automatically read ConFirm Rapid 20 Minute Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C-60°C for a fluorescent result.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233681: ConFirm 20 Minute Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233681
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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