510(k) · Cleared
ClearedAnemoCheck Home
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanguina, Inc. · KHG Whole Blood Hemoglobin Determination
Cleared on Sep 29, 2023 as substantially equivalent to K032203 (Hemocue, Inc., 2003) and 1 other predicate after a 493-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Sep 29, 2023
- Review
- 493 days
- Class
- Class II
- Product code
- KHG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K032203 (2003). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK032203 Hemocue Hemoglobin 201 + System Article 121704Hemocue, Inc. · 2003 · Recalled
- This deviceK221508 AnemoCheck HomeSanguina, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032203 | Hemocue Hemoglobin 201 + System Article 121704 | Hemocue, Inc. | 2003 | 1 |
| 0 (this device) | K221508 | AnemoCheck Home | Sanguina, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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…oglobin assays Regulation section: CFR 864.7500 Device Classification: Class II 5. Substantial Equivalence: HemoCue Hemoglobin 201+ System (K032203) AnemiaPro Self Screener (K042379) 6. Device Description: AnemoCheck Home is a home use with prescription… | 2003 |
| * | K042379 | Anemiapro Self-ScreenerSummary page 4…CFR 864.7500 Device Classification: Class II 5. Substantial Equivalence: HemoCue Hemoglobin 201+ System (K032203) AnemiaPro Self Screener (K042379) 6. Device Description: AnemoCheck Home is a home use with prescription anemia test that is semi- quantita… | 2004 |
| † | K163215 | AnemoCheck | 2017 |
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?
- 1 of the 2 ancestors has 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. 2023, 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?
AnemoCheck Home is intended for home use for the determination of hemoglobin level in whole blood from a finger stick by people over the age of 18. This device is intended for people with anemia caused by iron deficiency anemia, vitamin B12 deficiency anemia, folate deficiency anemia, or who have chronic anemia due to sickle cell disease or thalassemia. AnemoCheck Home tests are for in vitro diagnostic use only. Prescription Use Only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221508 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221508: AnemoCheck Home.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221508
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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