510(k) · Cleared
Recalled · Class II · 2013Rapid Yeast Plus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Diagnostic Systems, Inc. · JXB Kit, Identification, Yeast
Cleared on Jan 27, 1995 after a 184-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 2 times.
- Decided
- Jan 27, 1995
- Review
- 184 days
- Class
- Class I
- Product code
- JXB
- Recalls
- 2
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 JXB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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?
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 |
|---|---|---|---|---|
| Apr 4, 2013 | Class II | Z-0530-2014 | Labeling mix-ups | The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed. |
| Oct 28, 2009 | Not classified | Z-0870-2010 | Software design | There is an error in Version 1.0.77 of the electronic code compendium (ERIC) software. The error is limited to the database corresponding to the R8311007 RapID Yeast Plus System. The database erroneously includes Candida dubliniensis as… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All JXB devicesJXB Kit, Identification, Yeast: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXB
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · JXB
Too few JXB 510(k)s in any year since 2007 to give a median.
Recalls per year · JXB
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXB
6in 2025
MAUDE reports naming product code JXB, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 16 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 27 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 1 | 37 |
| 2022 | 0 | — | 2 | 10 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K943621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943621: Rapid Yeast Plus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943621
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026