510(k) · Cleared
ClearedBeckman Cholesterol Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman-Diagnostic Systems Group · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Oct 28, 1993 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 28, 1993
- Review
- 70 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK934046 Beckman Cholesterol ReagentBeckman-Diagnostic Systems Group · 1993
- Descendant · cites it directly · 1 of its ownK012221 Safe at Home Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK063852 Accessa Cholesterol PanelHome Access Health Corp. · 2007
- Descendant · cites it directly · 0 of its ownK011970 Biosafe Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK971505 Synchron Systems Cholesterol (Chol) ReagentBeckman Instruments, Inc. · 1997 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K012221Safe at Home Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 2002 · cites it directly1descendant
- K063852Accessa Cholesterol PanelHome Access Health Corp. · 2007 · 2 generations on0descendants
- K011970Biosafe Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 2001 · cites it directly0descendants
- K971505Synchron Systems Cholesterol (Chol) ReagentBeckman Instruments, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934046 | Beckman Cholesterol Reagent | Beckman-Diagnostic Systems Group | 1993 | — |
| +1 | K012221 | Safe at Home Cholesterol Profile Blood Collection and Transport System | Biosafe Laboratories, Inc. | 2002 | — |
| +2 | K063852 | Accessa Cholesterol Panel | Home Access Health Corp. | 2007 | — |
| +1 | K011970 | Biosafe Cholesterol Profile Blood Collection and Transport System | Biosafe Laboratories, Inc. | 2001 | — |
| +1 | K971505 | Synchron Systems Cholesterol (Chol) Reagent | Beckman Instruments, Inc. | 1997 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 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 CHH? 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 CHH device
- #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (4)
3 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, K012221 (Biosafe Laboratories, Inc., 2002) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K934046 · printed Nov 4, 2026
Cite this page
510(k) Report. “K934046: Beckman Cholesterol Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934046
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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