510(k) · Cleared
ClearedHemosite Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gds Technology, LLC · KHG Whole Blood Hemoglobin Determination
Cleared on Jan 14, 2000 as substantially equivalent to K973649 (Gds Technology, LLC, 1998) after a 43-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Jan 14, 2000
- Review
- 43 days
- Class
- Class II
- Product code
- KHG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K896873 (1990). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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 |
|---|---|---|---|
| * | K973649 | Hemosite Test SystemSummary page 2…System .vs. Reference Slope= 0.9717 Intercept= 0.0397 Correlation Coefficient= 0.91 Since there are no differences in the product relative to the HemoSite® Test System (K973649), no other product evaluations were required. CONCLUSION The clinical data demonstrated that whole blood HemoSite® results with… | 1998 |
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 10 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- None of the 2 ancestors has a recall.
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 HemoSite® Test System is a device for in vitro diagnostic use only.
The GDS® Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® Meter.
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/K994073 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994073: Hemosite Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994073
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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