510(k) · Cleared
ClearedSterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilucent, Inc. · FRC Indicator, Biological Sterilization Process
Cleared on Oct 22, 2019 as substantially equivalent to K140589 (Mesa Laboratories, Inc., 2014) and 1 other predicate after an 88-day review. Its family tree reaches back 5 generations to 2005. 2 later devices descend from it.
- Decided
- Oct 22, 2019
- Review
- 88 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K042450 (2005). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK042450 Sterrad NX Challenge PackAdvanced Sterilization Products · 2005
- 4 generations backK051643 Sterrad Sterilizer Cyclesure Test PackAdvanced Sterilization Products · 2005
- 3 generations backK073618 Verify Sirius Biological Indicator Challenge PackSTERIS Corporation · 2009
- 2 generations backK092906 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2009
- 1 generation backK141312 Sterilucent Process Challenge DeviceSterilucent, Inc. · 2014
- This deviceK192001 Sterilucent self-Contained Biological Indicator, Sterilucent Lumen…Sterilucent, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK233814 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge…3M Company · 2024
- Descendant · 2 generations on · 0 of its ownK241542 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge…3M Company · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042450 | Sterrad NX Challenge Pack | Advanced Sterilization Products | 2005 | — |
| −4 | K051643 | Sterrad Sterilizer Cyclesure Test Pack | Advanced Sterilization Products | 2005 | — |
| −3 | K073618 | Verify Sirius Biological Indicator Challenge Pack | STERIS Corporation | 2009 | — |
| −2 | K092906 | Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization | STERIS Corporation | 2009 | — |
| −1 | K141312 | Sterilucent Process Challenge Device | Sterilucent, Inc. | 2014 | — |
| 0 (this device) | K192001 | Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle… | Sterilucent, Inc. | 2019 | — |
| +1 | K233814 | 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack… | 3M Company | 2024 | — |
| +2 | K241542 | 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack… | 3M Company | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K140589 | Sterrad Cyclesure 24 Plus Biological IndicatorSummary page 4…n Process Indicator Classification: 21 CFR 880.2800(a) Class: II Product Code: FRC Predicate Device(s): STERRAD® CYCLESURE® 24 Plus BI (K140589) Sterilucent Process Challenge Device (K141312) Device Description: The Sterilucent Self-Contained Biol… | 2014 |
| * | K141312 | Sterilucent Process Challenge DeviceSummary page 4…II Product Code: FRC Predicate Device(s): STERRAD® CYCLESURE® 24 Plus BI (K140589) Sterilucent Process Challenge Device (K141312) Device Description: The Sterilucent Self-Contained Biological Indicator (SCBI) is a sterilization proc… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233814 | 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™… | 2024 | 1 |
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 14 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K233814 (3M Company, 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The Sterilucent SCBI is intended to be used as a standard method for frequent monitoring of the Sterilucent HC 80TT Sterilizer Cycles, when incorporated into a test pack. The Sterilucent Process Challenge Device (PCD) test pack is used for routine monitoring of the Sterilucent HC 80TT Sterilizer Lumen and Flexible Cycles. The Sterilucent PCD may also be used for performance qualification of the Sterilucent HC 80TT sterilizer Lumen and Flexible Cycles…
Read the full statement (130 words)
The Sterilucent SCBI is intended to be used as a standard method for frequent monitoring of the Sterilucent HC 80TT Sterilizer Cycles, when incorporated into a test pack.
The Sterilucent Process Challenge Device (PCD) test pack is used for routine monitoring of the Sterilucent HC 80TT Sterilizer Lumen and Flexible Cycles. The Sterilucent PCD may also be used for performance qualification of the Sterilucent HC 80TT sterilizer Lumen and Flexible Cycles during initial installation, after relocation, major repairs or mal functions, or after sterilization process failures.
Both the Sterilucent Lumen Cycle PCD and the Sterilucent Flexible Cycle PCD are intended to have greater resistance than the stand alone SCBI. Both devices are designed to have increased resistance beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192001 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192001: Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192001
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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