510(k) · Cleared
ClearedSteris Steam PI
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 Jan 11, 2012 as substantially equivalent to K060103 (Albert Browne, Ltd., 2006) after a 159-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Jan 11, 2012
- Review
- 159 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K932129 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK932129 3M Autoclave Tapes3M Company · 1994
- 3 generations backK992767 Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2000
- 2 generations backK032801 Modified Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2003
- 1 generation backK060103 Albert Browne LTD. Verify Steam Value IndicatorsAlbert Browne, Ltd. · 2006
- This deviceK112256 Steris Steam PISTERIS Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932129 | 3M Autoclave Tapes | 3M Company | 1994 | — |
| −3 | K992767 | Browne Packaging and Label Steam Process Indicator | Albert Browne, Ltd. | 2000 | — |
| −2 | K032801 | Modified Browne Packaging and Label Steam Process Indicator | Albert Browne, Ltd. | 2003 | — |
| −1 | K060103 | Albert Browne LTD. Verify Steam Value Indicators | Albert Browne, Ltd. | 2006 | — |
| 0 (this device) | K112256 | Steris Steam PI | STERIS Corporation | 2012 | — |
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? (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 |
|---|---|---|---|
| * | K060103 | Albert Browne LTD. Verify Steam Value IndicatorsSummary page 2…ation process indicators (21 CFR 880.2800 (b), Product Code JOJ) 2. Predicate Device Verify STEAM Value Indicators (K060 103) 3. Device Description The proposed STERIS TEA 7a is composed of a single ink printed on polyethylene terephthalate… | 2006 |
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 18 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K060103.
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. 2012, 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 STERIS TEA 7r is a process indicator that undergoes a visual color change from a pink to brown color when exposed to the following steam sterilization cycle parameters:
* 121°C (250°F), 30 min, steam sterilization gravity cycle
* 132°C (270°F), 15 min, steam sterilization gravity cycle
* 135°C (275°F), 10 min, steam sterilization gravity cycle
* 132°C (270°F), 4 min, steam sterilization dynamic air removal cycle
* 135°C (275°F), 3 min, steam sterilization dynamic air removal cycle
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112256: Steris Steam PI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112256
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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