510(k) · Cleared
ClearedSTERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Sterilization Products, Inc. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Jul 5, 2024 as substantially equivalent to K111518 (Advanced Sterilization Products, 2012) and 2 other predicates after a 196-day review. Its family tree reaches back 11 generations to 2002.
- Decided
- Jul 5, 2024
- Review
- 196 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K994055 (2002). 26 ancestors in all, the oldest K900771 (1990). No later device cites it as a predicate yet.
- Root · 11 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
- 7 generations between
- 3 generations backK170039 STERRAD VELOCITY Biological Indictator and ReaderAdvanced Sterilization Products (Asp) · 2017
- 2 generations backK182404 STERRAD VELOCITY Biological IndicatorAdvanced Sterilization Products (Asp) · 2018
- 1 generation backK192025 STERRAD VELOCITY Biological Indicator/Process Challenge Device and…Advanced Sterilization Products (Asp) · 2020
- This deviceK234084 STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE®…Advanced Sterilization Products, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
- 10 generations backK031226 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2003 · Recalled
- 9 generations backK071014 Modification to Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2007
- 8 generations backK102884 Sterrad Cyclesure 24 Biological IndicatorAdvanced Sterilization Products · 2011
- 7 generations backK111375 Sterrad (R) Cyclesure (R) 24 Biological IndicatorAdvanced Sterilization Products · 2012
- 6 generations backK123017 Sterrad Cyclesure 24 Biological Indicator Model 14324Advanced Sterilization Products · 2012
- 5 generations backK140392 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company · 2014
- 4 generations backK152060 3M Attest Rapid Readout Biological Indicator 12953M Company · 2015
- 3 generations backK170039 STERRAD VELOCITY Biological Indictator and ReaderAdvanced Sterilization Products (Asp) · 2017
- 2 generations backK182404 STERRAD VELOCITY Biological IndicatorAdvanced Sterilization Products (Asp) · 2018
- 1 generation backK192025 STERRAD VELOCITY Biological Indicator/Process Challenge Device and…Advanced Sterilization Products (Asp) · 2020
- This deviceK234084 STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE®…Advanced Sterilization Products, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K994055 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2002 | 1 |
| −10 | K031226 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2003 | 1 |
| −9 | K071014 | Modification to Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2007 | — |
| −8 | K102884 | Sterrad Cyclesure 24 Biological Indicator | Advanced Sterilization Products | 2011 | — |
| −7 | K111375 | Sterrad (R) Cyclesure (R) 24 Biological Indicator | Advanced Sterilization Products | 2012 | — |
| −6 | K123017 | Sterrad Cyclesure 24 Biological Indicator Model 14324 | Advanced Sterilization Products | 2012 | — |
| −5 | K140392 | 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader | 3M Company | 2014 | — |
| −4 | K152060 | 3M Attest Rapid Readout Biological Indicator 1295 | 3M Company | 2015 | — |
| −3 | K170039 | STERRAD VELOCITY Biological Indictator and Reader | Advanced Sterilization Products (Asp) | 2017 | — |
| −2 | K182404 | STERRAD VELOCITY Biological Indicator | Advanced Sterilization Products (Asp) | 2018 | — |
| −1 | K192025 | STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader | Advanced Sterilization Products (Asp) | 2020 | — |
| 0 (this device) | K234084 | STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical… | Advanced Sterilization Products, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2015 | 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 JOJ? 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 JOJ device
- #1 K261992 3M™ Attest™ Steam Chemical Integrator (1243A…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K111518 | Sterrad Chemial Indicator Strip Model 14100Summary page 8…Class II Product Code: JOJ CFR Section: 21 CFR 880.2800 Predicate Device STERRAD® Chemical Indicator Strip cleared under 510(k) K111518 on October 3, 2012. K234084 Page 1 of 19 ==… | 2012 |
| * | K111519 | Sterrad Sealsure Chemical Indicator Tape Model 14202Summary page 13…Class II Product Code: JOJ CFR Section: 21 CFR 880.2800 Predicate Device STERRAD® SEALSURE® Chemical Indicator Tape cleared under 510(k) K111519 on October 3, 2012. K234084 Page 6 of 19 ==… | 2012 |
| * | K192025 | STERRAD VELOCITY Biological Indicator/Process Challenge Device and ReaderSummary page 18…21 CFR 880.2800 Predicate Device STERRAD VELOCITY® Biological Indicator/Process Challenge Device (BI/PCD) and STERRAD VELOCITY® Reader cleared under 510(k) K192025 on January 23, 2020. K234084 Page 11 of 19… | 2020 |
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 22 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 26 ancestors have a recall of any class.
How does its category compare?
All JOJ devicesJOJ Indicator, Physical/Chemical Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · JOJ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOJ
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOJ
12in 2025
MAUDE reports naming product code JOJ, 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 | 8 | 140 | 0 | 1 |
| 2008 | 9 | 57 | 2 | 1 |
| 2009 | 7 | 188 | 2 | 9 |
| 2010 | 6 | 115 | 0 | 3 |
| 2011 | 13 | 151 | 2 | 1 |
| 2012 | 7 | 224 | 0 | 8 |
| 2013 | 6 | 212 | 0 | 6 |
| 2014 | 6 | 198 | 0 | 11 |
| 2015 | 8 | 188 | 0 | 7 |
| 2016 | 4 | 150 | 0 | 11 |
| 2017 | 7 | 172 | 0 | 35 |
| 2018 | 5 | 150 | 0 | 12 |
| 2019 | 12 | 38 | 0 | 8 |
| 2020 | 7 | 108 | 0 | 6 |
| 2021 | 4 | 87 | 1 | 29 |
| 2022 | 8 | 90 | 0 | 23 |
| 2023 | 4 | 53 | 1 | 39 |
| 2024 | 12 | 71 | 0 | 25 |
| 2025 | 6 | 90 | 0 | 12 |
| 2026 | 3 | 30 | 0 | — |
What is it indicated for?
The STERRAD™ Chemical Indicator (Cl) Strip is a process indicator per ISO 11140-1:2014 [Type 1] (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in the following STERRAD™ Sterilization Systems: • STERRAD™ lO0S Sterilization System • STERRAD NX™ Sterilization System o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology • STERRAD™ lO0NX Sterilization System o…
Read the full statement (322 words)
The STERRAD™ Chemical Indicator (Cl) Strip is a process indicator per ISO 11140-1:2014 [Type 1] (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in the following STERRAD™ Sterilization Systems:
• STERRAD™ lO0S Sterilization System
• STERRAD NX™ Sterilization System
o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology
• STERRAD™ lO0NX Sterilization System
o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear Technology
o ULTRA GI™ Cycle with Integrated ALLClear Technology
STERRAD™ SEALSURE™ Chemical Indicator Tape is a process indicator (ISO 1114 0-1:2014 [Type 1]) intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD™ Sterilization Systems:
• STERRAD™ lO0S Sterilization System
• STERRAD NX™ Sterilization System
o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology
• STERRAD™ lO0NX Sterilization System
o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
o ULTRA GI™ Cycle with Integrated ALLClear™ Technology
The color of the STERRAD SEALSURE Chemical Indicator Tape changes from red to gold (or lighter) indicated by comparator bar when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.
The STERRAD VELOCITY™ Biological Indicator (B1)/Process Challenge Device (PCD), in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring and/or periodic testing of the following STERRAD™ Systems:
• STERRAD™ lO0NX Sterilization System
o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
o ULTRA GI™ Cycle with Integrated ALLClear Technology (for frequent monitoring only).
• STERRAD NX™ Sterilization System
o (STANDARD AND ADVANCED Cycles) with and without ALLClear™ Technology
• STERRAD™ lO0S Sterilization System
The ULTRA GI™ Process Challenge Device (PCD) Vial is used with the STERRAD VELOCITY™ Biological Indicator (Bl) for periodic testing and frequent monitoring of the ULTRA GI™ Cycle in the STERRAD™ l00NX Sterilization System with ALLClear™ Technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K234084: STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K234084
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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