510(k) · Cleared
Recalled · Class II · 2013Steritec Steam Biological Test Pack with Instant Readout Integrator, Model BI 103
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steritec Products, Inc. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on May 15, 2000 after a 7-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- May 15, 2000
- Review
- 7 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK001444 Steritec Steam Biological Test Pack with Instant Readout Integrator…Steritec Products, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK022706 Spsmedical Sporview Steam BI Test PackSpsmedical Supply Corp. · 2002
- Descendant · 2 generations on · 1 of its ownK051173 Spsmedical Sporview Plus Steam BI Test PackSpsmedical Supply Corp. · 2005
- Descendant · 3 generations on · 0 of its ownK140620 Sporview Plus BI Test PackCrosstex International · 2014
- Descendant · cites it directly · 0 of its ownK031647 Biosign Ssi Biological Test Pack with Instant Readout IntegratorGetinge USA, Inc. · 2003
Most influential descendants
Showing 4 of 4 · See all- K022706Spsmedical Sporview Steam BI Test PackSpsmedical Supply Corp. · 2002 · cites it directly2descendants
- K051173Spsmedical Sporview Plus Steam BI Test PackSpsmedical Supply Corp. · 2005 · 2 generations on1descendant
- K140620Sporview Plus BI Test PackCrosstex International · 2014 · 3 generations on0descendants
- K031647Biosign Ssi Biological Test Pack with Instant Readout IntegratorGetinge USA, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001444 | Steritec Steam Biological Test Pack with Instant Readout Integrator, Model BI… | Steritec Products, Inc. | 2000 | — |
| +1 | K022706 | Spsmedical Sporview Steam BI Test Pack | Spsmedical Supply Corp. | 2002 | — |
| +2 | K051173 | Spsmedical Sporview Plus Steam BI Test Pack | Spsmedical Supply Corp. | 2005 | — |
| +3 | K140620 | Sporview Plus BI Test Pack | Crosstex International | 2014 | — |
| +1 | K031647 | Biosign Ssi Biological Test Pack with Instant Readout Integrator | Getinge USA, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
2 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 |
|---|---|---|---|---|
| Jun 10, 2013 | Class II | Z-1828-2013 | Nonconforming Material/Component | Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. |
| Jun 10, 2013 | Class II | Z-1829-2013 | Nonconforming Material/Component | Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022706 (Spsmedical Supply Corp., 2002) has gone furthest, with 2 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K001444 · printed Nov 5, 2026
Cite this page
510(k) Report. “K001444: Steritec Steam Biological Test Pack with Instant Readout Integrator, Model BI 103.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001444
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026