510(k) · Cleared
Recalled · Class III · 2022VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Mar 21, 2017 as substantially equivalent to K002741 (Albert Browne, Ltd., 2002) and 5 other predicates after a 172-day review. Its family tree reaches back 5 generations to 1994. It has been recalled once.
- Decided
- Mar 21, 2017
- Review
- 172 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 5 generations to K932129 (1994). 20 ancestors in all, the oldest K801109 (1980). No later device cites it as a predicate yet.
- Root · 5 generations backK932129 3M Autoclave Tapes3M Company · 1994
- 4 generations backK992767 Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2000
- 3 generations backK032801 Modified Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2003
- 2 generations backK073683 Verify Challenge Packs - Version 2STERIS Corporation · 2008
- 1 generation backK103053 Verify 270FP Challenge PackSTERIS Corporation · 2011 · Recalled
- This deviceK162758 VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators…STERIS Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932129 | 3M Autoclave Tapes | 3M Company | 1994 | — |
| −4 | K992767 | Browne Packaging and Label Steam Process Indicator | Albert Browne, Ltd. | 2000 | — |
| −3 | K032801 | Modified Browne Packaging and Label Steam Process Indicator | Albert Browne, Ltd. | 2003 | — |
| −2 | K073683 | Verify Challenge Packs - Version 2 | STERIS Corporation | 2008 | — |
| −1 | K103053 | Verify 270FP Challenge Pack | STERIS Corporation | 2011 | 1 |
| 0 (this device) | K162758 | VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie… | STERIS Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (6)
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 |
|---|---|---|---|
| * | K002741 | Browne TST Single Use Bowie Dick/Integrator Test PackSummary page 10…fication Number: 21 CFR 880.2800 (b) Product Code: JOJ 2. Predicate Devices 510(k) # Device Name K002741 Browne TST Dual Use Test Pack K070461 VERIFY Steam Indicators K071895 VERIFY 275F 3 Indi… | 2002 |
| * | K070461 | Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4Summary page 10…Code: JOJ 2. Predicate Devices 510(k) # Device Name K002741 Browne TST Dual Use Test Pack K070461 VERIFY Steam Indicators K071895 VERIFY 275F 3 Indicator K073683 VERIFY Challenge Packs –… | 2007 |
| * | K071895 | Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSummary page 10…510(k) # Device Name K002741 Browne TST Dual Use Test Pack K070461 VERIFY Steam Indicators K071895 VERIFY 275F 3 Indicator K073683 VERIFY Challenge Packs – Versions 2 K083643 VERIFY 275F… | 2007 |
| * | K073683 | Verify Challenge Packs - Version 2Summary page 10…K002741 Browne TST Dual Use Test Pack K070461 VERIFY Steam Indicators K071895 VERIFY 275F 3 Indicator K073683 VERIFY Challenge Packs – Versions 2 K083643 VERIFY 275F Gravity Indicator K103053 VERIFY… | 2008 |
| * | K083643 | Verify 275F Gravity IndicatorsSummary page 10…K070461 VERIFY Steam Indicators K071895 VERIFY 275F 3 Indicator K073683 VERIFY Challenge Packs – Versions 2 K083643 VERIFY 275F Gravity Indicator K103053 VERIFY 270FP Challenge Pack The proposed devices are identical… | 2009 |
| * | K103053 | Verify 270FP Challenge PackSummary page 10…K071895 VERIFY 275F 3 Indicator K073683 VERIFY Challenge Packs – Versions 2 K083643 VERIFY 275F Gravity Indicator K103053 VERIFY 270FP Challenge Pack The proposed devices are identical to the predicates in performance and composition w… | 2011 |
| † | K965154 | TST Control Integrator for Steam Autoclave | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2022 | Class III | Z-1736-2022 | Process control | Product contains incorrect chemical indicators in packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 20 ancestors have a recall of any class.
- 1 other device also cites its predicate K002741.
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. 2017, 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 Verify® Steam Indicators are emulating indicators intended for use in steam sterilization. The Verify® Steam Indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The indicator models and their cycle temperatures, types, and times are: MODEL TEMPERATURE STERILIZATION TYPE TIME Verity 250F 30 250°F (121°C) gravity steam 30 minutes Verify 270F 15 270°F (132°C) gravity steam 15 minutes…
Read the full statement (546 words)
The Verify® Steam Indicators are emulating indicators intended for use in steam sterilization. The Verify® Steam Indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The indicator models and their cycle temperatures, types, and times are:
MODEL TEMPERATURE STERILIZATION TYPE TIME
Verity 250F 30 250°F (121°C) gravity steam 30 minutes
Verify 270F 15 270°F (132°C) gravity steam 15 minutes
Verify 270F 3-10 270°F (132°C) gravity flash steam 3 or 10 minutes
Verity 270F 4 270°F (132°C) SFPP, pre-vacuum and Express steam 4 minutes
The Verify® 275F 3 Indicator is a chemical indicator intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The Verify® 275F 3 Indicator is an emulating indicator intended for use in steam sterilization. The indicator changes color from yellow to blue/purple when exposed to 275°F (135°C) pre-vacuum sterilization cycles for 3 minutes as indicated in the following table:
MODEL TEMPERATURE STERILIZATION TYPE TIME
Verify 275F 3 275°F (135°C) Pre-vacuum steam 3 minutes
The Verify® 275F Gravity Indicators are chemical integrators which meet ANSI/AAMI 1140-1:2005 for emulating indicators intended for use in steam sterilization. The Verify® 275F Gravity Indicators change color from yellow to blue/purple when exposed to 275°F (135°C) and to the appropriate cycle type and duration. The Verify® 275F Indicators models and their cycle types and times are:
MODEL TEMPERATURE STERILIZATION TYPE TIME
Verify 275F 3-10 275°F (135°C) Gravity flash steam 3 and 10 minutes
Verify 275F 10 275°F (135°C) Gravity steam 10 minutes
The Verify® Challenge Packs —Version 2 - are test packs consisting of an emulating indicator surrounded by a steam penetration barrier, intended for use in steam sterilization. The Verify® Challenge Packs indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The challenge pack models and their cycle temperatures, types, and times are:
- Verify® 270F 4 - 270°F (132°C) Pre-vacuum, Steam Flush Pressure Pulse (SFPP), 4 minutes
- Verify® 275F 3 - 275°F (135°C) Pre-vacuum 3 minutes
There is a process indicator outside of the packs which undergoes a visual color change when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).
The Verify® 270FP Challenge Pack is a test pack consisting of three emulating indicator inks situated on a test sheet surrounded by a steam penetration barrier, intended for use in SFPP (steam-flush pressure-pulse) and pre-vacuum steam sterilization for load release. The Verify® 270FP Challenge Pack indicators change color from yellow to blue/purple when exposed to the following conditions at 270°F (132°C):
- 4 minute indicator - SFPP and pre-vacuum steam sterilization for 4 minutes.
- 10 minute indicator - Pre-vacuum steam sterilization for 10 minutes.
- 20 minute indicator - Pre-vacuum steam sterilization for 20 minutes.
The Browne TST Dual Use Test Pack is a chemical sterilization process monitor that can be used as either:
- Bowie Dick Test - in an empty chamber to monitor air removal and steam penetration during the vacuum stage of 132°C (270°F), 134°C (273°F) , and 135 °C (275 °F) test cycles.
- Challenge Pack - in a loaded chamber to monitor steam penetration during the hold/plateau stage of 132°C (270°F), 134 °C (273 °F), and 135 °C (275 °F) steam sterilization 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/K162758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162758: VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162758
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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