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 Aug 31, 1998 as substantially equivalent to K896873 (Coulter Corp., 1990) after a 340-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Aug 31, 1998
- Review
- 340 days
- Class
- Class II
- Product code
- KHG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896873 (1990). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K994073Hemosite Test SystemGds Technology, LLC · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896873 | Coulter JT3 | Coulter Corp. | 1990 | — |
| 0 (this device) | K973649 | Hemosite Test System | Gds Technology, LLC | 1998 | — |
| +1 | K994073 | Hemosite Test System | Gds Technology, LLC | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (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 |
|---|---|---|---|
| * | K896873 | Coulter JT3Summary page 1…98 Trade Name: HemoSite® Test System Common Name: Whole Blood Hemoglobin Test Classification Name: Whole Blood Hemoglobin Determination Comparison Device: Coulter® JT (K896873) Device Description: The HemoSite® Test Cards are dry-chemistry Test Cards that contain chemicals which react and produce colo… | 1990 |
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 |
|---|---|---|---|
| K994073 | Hemosite Test System | 2000 | 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?
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 GDS® HemoSite® Test System is a device for in vitro diagnostic use only. The GDS® HemoSite® 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/K973649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973649: 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/K973649
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