510(k) · Cleared
ClearedAnemoCheck
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanguina, LLC · KHG Whole Blood Hemoglobin Determination
Cleared on Sep 13, 2017 as substantially equivalent to K032203 (Hemocue, Inc., 2003) and 1 other predicate after a 301-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Sep 13, 2017
- Review
- 301 days
- Class
- Class II
- Product code
- KHG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971998 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971998 | Advia 120 Hematology System, in Vitro Diagnostic System | Bayer Corp. | 1997 | 2 |
| −1 | K042251 | Bayer Advia 2120 Hematology Analyzer with Autoslide System | Bayer Healthcare, LLC | 2004 | — |
| 0 (this device) | K163215 | AnemoCheck | Sanguina, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 KHG? 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 KHG device
- #1 K221508 AnemoCheck Homescore 6.1 · 1 generation · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K032203 | Hemocue Hemoglobin 201 + System Article 121704Summary page 4…& Citations: Product Code: KHG Regulation Number: 864.7500 Device Class: 2 5. Predicate Device: Hemocue® Hemoglobin Hb 201+ Analyzing System K032203 Siemens ® Advia 2120i (K042251) Page 5-1 of 5-2 ==… | 2003 |
| * | K042251 | Bayer Advia 2120 Hematology Analyzer with Autoslide SystemSummary page 4…Regulation Number: 864.7500 Device Class: 2 5. Predicate Device: Hemocue® Hemoglobin Hb 201+ Analyzing System K032203 Siemens ® Advia 2120i (K042251) Page 5-1 of 5-2… | 2004 |
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.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K032203.
How does its category compare?
All KHG devicesKHG Whole Blood Hemoglobin Determination: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · KHG
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KHG
Too few KHG 510(k)s in any year since 2007 to give a median.
Recalls per year · KHG
No recall names KHG since 2007.
Adverse event reports per year · KHG
1in 2025
MAUDE reports naming product code KHG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AnemoCheck is an in vitro diagnostic semi-quantitative assay for use in point-of-care, clinical and doctor office laboratories for the determination of hemoglobin level and estimation of hematocrit percentage (within normal hemoglobin range) in anticoagulated (K2EDTA, heparin or citrate) whole blood (capillary or venous). AnemoCheck should not be used to evaluate neonatal samples (birth - 1 month).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163215: AnemoCheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163215
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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