510(k) · Cleared
ClearedBuehlmann Lab as, Ace Angio Conv Enzyme Kin Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Laboratory Products Co., Ltd. · KQN Radioassay, Angiotensin Converting Enzyme
Cleared on Aug 26, 1991 after a 45-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
- Decided
- Aug 26, 1991
- Review
- 45 days
- Class
- Class II
- Product code
- KQN
- Recalls
- None
- 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 KQN? 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KQN devicesKQN Radioassay, Angiotensin Converting Enzyme: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KQN
FDA has decided no KQN device since 2007.
Median 510(k) review, days · KQN
Too few KQN 510(k)s in any year since 2007 to give a median.
Recalls per year · KQN
No recall names KQN since 2007.
Adverse event reports per year · KQN
No MAUDE report names KQN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 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/K913091 · printed Nov 4, 2026
Cite this page
510(k) Report. “K913091: Buehlmann Lab as, Ace Angio Conv Enzyme Kin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K913091
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026