510(k) · Cleared
Recalled · Class III · 2022Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4
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 Jul 17, 2007 as substantially equivalent to K960441 (Steritec Products Mfg Co, Inc., 1997) after a 151-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 17, 2007
- Review
- 151 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960441 (1997). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK960441 Steritec Integraph Model CI-101Steritec Products Mfg Co, Inc. · 1997
- This deviceK070461 Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10…STERIS Corporation · 2007
- Descendant · cites it directly · 0 of its ownK182724 CelerityTM 10 STEAM Chemical IndicatorSTERIS Corporation · 2018
- Descendant · cites it directly · 0 of its ownK162758 VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators…STERIS Corporation · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK102894 Classix Chemical Sterilization IndicatorPropper Mfg. Co., Inc. · 2011
Most influential descendants
Showing 3 of 3 · See all- K182724CelerityTM 10 STEAM Chemical IndicatorSTERIS Corporation · 2018 · cites it directly0descendants
- K162758VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test…STERIS Corporation · 2017 · cites it directly0descendants
- K102894Classix Chemical Sterilization IndicatorPropper Mfg. Co., Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960441 | Steritec Integraph Model CI-101 | Steritec Products Mfg Co, Inc. | 1997 | — |
| 0 (this device) | K070461 | Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4 | STERIS Corporation | 2007 | — |
| +1 | K182724 | CelerityTM 10 STEAM Chemical Indicator | STERIS Corporation | 2018 | — |
| +1 | K162758 | VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie… | STERIS Corporation | 2017 | 1 |
| +1 | K102894 | Classix Chemical Sterilization Indicator | Propper Mfg. Co., Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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? (4)
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 |
|---|---|---|---|
| * | K960441 | Steritec Integraph Model CI-101Summary page 2…monitor a 4 minute 270 0 F/132 0 C SFPP, pre-vacuum and Express steam sterilization cycle. Cardinal is a private label brand produced by Steritec under K960441. June 12, 2007 Page B-2 STERIS Additiona… | 1997 |
| * | — | 3M SteriGage Chemical Indicators Named without a submission number | |
| * | — | DANA SteriScan Indicators Named without a submission number | |
| * | — | STERIS Verify Integrators Named without a submission number |
What descends from it? (3)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class III | Z-1793-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2007, 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: Verify 250F 30 250°F (121°C) gravity steam 30 minutes Verify 270F 15 270°F (132 0 C) gravity steam 15 minutes Verify 270F 3-10 270 0 F (132 0 C)…
Read the full statement (96 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:
Verify 250F 30 250°F (121°C) gravity steam 30 minutes
Verify 270F 15 270°F (132 0 C) gravity steam 15 minutes
Verify 270F 3-10 270 0 F (132 0 C) gravity flash steam 3 or 10 minutes
Verify 270F 4 270°F (132°C) Steam Flush Pressure Pulse 4 minutes
(SFPP), pre-vacuum and
Express steam
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070461: Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070461
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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