510(k) · Cleared
ClearedAnemiapro Self-Screener
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosafe Laboratories, Inc. · KHG Whole Blood Hemoglobin Determination
Cleared on Dec 15, 2004 after a 105-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Dec 15, 2004
- Review
- 105 days
- Class
- Class II
- Product code
- KHG
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK042379 Anemiapro Self-ScreenerBiosafe Laboratories, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK221508 AnemoCheck HomeSanguina, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K221508AnemoCheck HomeSanguina, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042379 | Anemiapro Self-Screener | Biosafe Laboratories, Inc. | 2004 | — |
| +1 | K221508 | AnemoCheck Home | Sanguina, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | — | Cell Dyn 3700 Analyzer Named without a submission number | |
| * | — | HemoCue B-Hemoglobin Instrument Named without a submission number |
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 |
|---|---|---|---|
| K221508 | AnemoCheck Home | 2023 | 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?
- Of its descendants, K221508 (Sanguina, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KHG devicesKHG Whole Blood Hemoglobin Determination: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 AnemiaProTM Self-Screener is intended for over-the-counter distribution, for the determination of hemoglobin concentration in a self-collected capillary whole blood sample. The device is not intended for use in neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042379: Anemiapro Self-Screener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042379
Report an extraction error
Are you the manufacturer?
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