510(k) · Cleared
ClearedBiosign Ssi Biological Test Pack with Instant Readout Integrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Getinge USA, Inc. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Jul 29, 2003 as substantially equivalent to K922212 (Mdt Corp., Inc., 1992) and 1 other predicate after a 63-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jul 29, 2003
- Review
- 63 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922212 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK922212 MDT Castle Biosign Test PackMdt Corp., Inc. · 1992
- This deviceK031647 Biosign Ssi Biological Test Pack with Instant Readout IntegratorGetinge USA, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922212 | MDT Castle Biosign Test Pack | Mdt Corp., Inc. | 1992 | — |
| 0 (this device) | K031647 | Biosign Ssi Biological Test Pack with Instant Readout Integrator | Getinge USA, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (2)
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 |
|---|---|---|---|
| * | K922212 | MDT Castle Biosign Test PackSummary page 1…eadout Integrator Classification: Indicator, Biological Sterilization Process - Class II, 80 FRC Predicate Device: Castle Biosign EZ-VU Biological Test Pack (K922212) SteriTec Biological Test Pack with Instant Readout Integrator (t<OO1444) Device Description: The Getinge Bio… | 1992 |
| * | K001444 | Steritec Steam Biological Test Pack with Instant Readout Integrator, Model BI 103 | 2000 |
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?
- 1 of the 2 ancestors has 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.
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 Getinge Biosign SSI Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-Vacuum steam steriiizers operating at 132°C. The instant readout integrator card gives the operator a prediction ofthe biological test outcome. When fie chemical integrator *PASS" changes from purple to green, it indicates correct exposure anditions of temperature, time and steam.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031647 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031647: Biosign Ssi Biological Test Pack with Instant Readout Integrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031647
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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