510(k) · Cleared
ClearedSafe at Home Cholesterol Profile Blood Collection and Transport System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosafe Laboratories, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Apr 3, 2002 as substantially equivalent to K934046 (Beckman-Diagnostic Systems Group, 1993) and 2 other predicates after a 261-day review. Its family tree reaches back 1 generation to 1979. 1 later device descends from it.
- Decided
- Apr 3, 2002
- Review
- 261 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K781939 (1979). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK781939 Reagent Kit, TriglyceridesBeckman Instruments, Inc. · 1979
- This deviceK012221 Safe at Home Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK063852 Accessa Cholesterol PanelHome Access Health Corp. · 2007
Most influential descendants
Showing 1 of 1 · See all- K063852Accessa Cholesterol PanelHome Access Health Corp. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781939 | Reagent Kit, Triglycerides | Beckman Instruments, Inc. | 1979 | — |
| 0 (this device) | K012221 | Safe at Home Cholesterol Profile Blood Collection and Transport System | Biosafe Laboratories, Inc. | 2002 | — |
| +1 | K063852 | Accessa Cholesterol Panel | Home Access Health Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JKA? 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 JKA device
- #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K934046 | Beckman Cholesterol Reagent Our OCR of the scanned summary read K974046, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Beckman Synchron CX Systems Cholesterol (CHOL) Reagent”. | 1993 |
| * | K972041 | EZ HDL Cholesterol Reagent (Procedure 354)/EZ HDL Calibrator (354-5)Summary page 1…sterol (21 CFR 862.1475) Total Cholesterol Beckman Synchron Synchron CX Systems Cholesterol (CHOL) Reagent (K974046) HDL Cholesterol Sigma EZ HDL™ Cholesterol Reagent (K972041) Triglycerides Beckman Triglycerides Reagent Kit (K781939) The device is a kit containing the materials necessary to self-colle… | 1997 |
| * | K781939 | Reagent Kit, TriglyceridesSummary page 1…n Synchron CX Systems Cholesterol (CHOL) Reagent (K974046) HDL Cholesterol Sigma EZ HDL™ Cholesterol Reagent (K972041) Triglycerides Beckman Triglycerides Reagent Kit (K781939) The device is a kit containing the materials necessary to self-collect a capillary blood sample onto a filter paper card for tr… | 1979 |
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 |
|---|---|---|---|
| K063852 | Accessa Cholesterol Panel | 2007 | 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?
How does its category compare?
All JKA devicesJKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JKA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JKA
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JKA
13in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKA
6,089in 2025
MAUDE reports naming product code JKA, 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 | 4 | 281 | 3 | 73 |
| 2008 | 2 | — | 3 | 78 |
| 2009 | 2 | — | 3 | 42 |
| 2010 | 4 | 28 | 4 | 37 |
| 2011 | 0 | — | 14 | 67 |
| 2012 | 1 | — | 2 | 54 |
| 2013 | 3 | 244 | 1 | 33 |
| 2014 | 1 | — | 1 | 68 |
| 2015 | 1 | — | 6 | 41 |
| 2016 | 4 | 116 | 1 | 65 |
| 2017 | 2 | — | 2 | 2,039 |
| 2018 | 1 | — | 2 | 9,731 |
| 2019 | 6 | 181 | 9 | 6,469 |
| 2020 | 6 | 181 | 0 | 3,774 |
| 2021 | 4 | 217 | 3 | 3,610 |
| 2022 | 9 | 164 | 2 | 3,375 |
| 2023 | 17 | 189 | 2 | 4,400 |
| 2024 | 6 | 240 | 0 | 4,609 |
| 2025 | 7 | 115 | 13 | 6,089 |
| 2026 | 8 | 250 | 1 | — |
What is it indicated for?
The SAFE AT HOME CHOLESTEROL PROFILE Blood Collection and Transport System is intended for over-the-counter distribution, for the self-collection and transportation of dried capillary blood for in vitro diagnostic quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol in dried blood spots. This kit is not intended for use on neonates. LDL cannot be determined where the triglyceride value is greater than 400 mg/dL.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012221: Safe at Home Cholesterol Profile Blood Collection and Transport System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012221
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026