510(k) · Cleared
Recalled · 2011Appraise-Cardio Sample Collection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osborn Group, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Apr 14, 2000 as substantially equivalent to K983172 (Diabetes Technologies, Inc. (Dti), 1998) after a 157-day review. Its family tree reaches back 3 generations to 1986. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Apr 14, 2000
- Review
- 157 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K861697 (1986). 5 ancestors in all, the oldest K851636 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK861697 Self Assure/GHB (Capillary-Blood Collection Kit)Awareness Technology, Inc. · 1986
- 2 generations backK971919 Ezchek/Hba Blood Collection KitFlexsite Diagnostics, Inc. · 1997
- 1 generation backK983172 Accu-Base Hemoglobin A1C Sample Collection KitDiabetes Technologies, Inc. (Dti) · 1998
- This deviceK993787 Appraise-Cardio Sample Collection KitOsborn Group, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK021698 MY Allergy TestImmunetech Corporation · 2002 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K021698MY Allergy TestImmunetech Corporation · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K861697 | Self Assure/GHB (Capillary-Blood Collection Kit) | Awareness Technology, Inc. | 1986 | — |
| −2 | K971919 | Ezchek/Hba Blood Collection Kit | Flexsite Diagnostics, Inc. | 1997 | — |
| −1 | K983172 | Accu-Base Hemoglobin A1C Sample Collection Kit | Diabetes Technologies, Inc. (Dti) | 1998 | — |
| 0 (this device) | K993787 | Appraise-Cardio Sample Collection Kit | Osborn Group, Inc. | 2000 | — |
| +1 | K021698 | MY Allergy Test | Immunetech Corporation | 2002 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (1)
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 |
|---|---|---|---|
| * | K983172 | Accu-Base Hemoglobin A1C Sample Collection KitSummary page 1…uivalence: Substantial equivalence is claimed to the Diabetes Technologies, Inc. Accu-Base Hemoglobin A1c Sample Collection Kit, cleared for commercial distribution per K983172. Device Description: The Appraise-Cardio Sample Collection Kit is a Sample Collection Kit which is sent to the patient’'s home… | 1998 |
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 |
|---|---|---|---|
| K021698 | MY Allergy Test | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 9, 2011 | Not classified | Z-0542-2012 | Material/Component Contamination | Kits contain recalled Triad alcohol pads |
| Jan 9, 2011 | Not classified | Z-0535-2012 | Material/Component Contamination | Kits contain recalled Triad alcohol pads |
| Jan 9, 2011 | Not classified | Z-0579-2012 | Material/Component Contamination | Kits contain recalled Triad alcohol pads |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K021698 (Immunetech Corporation, 2002) has gone furthest, with 0 descendants of its own.
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 Appraise-Cardio sample collection kit is a prescription device indicated for use for obtaining a blood specimen which can be collected at the patient's home or at a physician’s office in a sample collection tube and delivered to the laboratory by mail. This specimen is then used to determine the patient’s total cholesterol, triglycerides, HDL and LDL values. The results are then mailed to the patient's physician for evaluation.
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/K993787 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993787: Appraise-Cardio Sample Collection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993787
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026