510(k) · Cleared
ClearedStak-Chex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck Laboratories, Inc. · JCN Control, Cell Counter, Normal And Abnormal
Cleared on May 28, 1991 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- May 28, 1991
- Review
- 50 days
- Class
- Class II
- Product code
- JCN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK911582 Stak-ChexStreck Laboratories, Inc. · 1991
- Descendant · cites it directly · 1 of its ownK992887 Stak-Chex Plus ReticsStreck Laboratories, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK090137 Stak-Chex Plus ReticsStreck · 2009
- Descendant · cites it directly · 0 of its ownK021922 Modification to Para 5XStreck Laboratories, Inc. · 2002
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911582 | Stak-Chex | Streck Laboratories, Inc. | 1991 | — |
| +1 | K992887 | Stak-Chex Plus Retics | Streck Laboratories, Inc. | 1999 | — |
| +2 | K090137 | Stak-Chex Plus Retics | Streck | 2009 | — |
| +1 | K021922 | Modification to Para 5X | Streck Laboratories, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 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 JCN? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K992887 (Streck Laboratories, Inc., 1999) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JCN devicesJCN Control, Cell Counter, Normal And Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JCN
FDA has decided no JCN device since 2007.
Median 510(k) review, days · JCN
Too few JCN 510(k)s in any year since 2007 to give a median.
Recalls per year · JCN
No recall names JCN since 2007.
Adverse event reports per year · JCN
2in 2007
MAUDE reports naming product code JCN, 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 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K911582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911582: Stak-Chex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911582
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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