510(k) · Cleared
ClearedKenz-Cardico 1201
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzuken Co., Ltd. · LOS (no longer in FDA’s product-code list)
Cleared on Jul 1, 1987 after a 148-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Jul 1, 1987
- Review
- 148 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK870443 Kenz-Cardico 1201Suzuken Co., Ltd. · 1987
- Descendant · cites it directly · 0 of its ownK172068 Kenz Cardico1211Suzuken Co., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K172068Kenz Cardico1211Suzuken Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K870443 | Kenz-Cardico 1201 | Suzuken Co., Ltd. | 1987 | — |
| +1 | K172068 | Kenz Cardico1211 | Suzuken Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 LOS? 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172068 | Kenz Cardico1211 | 2018 | 0 |
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, K172068 (Suzuken Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
https://510kreport.com/device/K870443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K870443: Kenz-Cardico 1201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K870443
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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