510(k) · Cleared
ClearedAvie Total HB Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mec Dynamics Corp · GKR System, Hemoglobin, Automated
Cleared on Jan 7, 2013 as substantially equivalent to K041234 (Hemocue, Inc., 2004) after a 207-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Jan 7, 2013
- Review
- 207 days
- Class
- Class II
- Product code
- GKR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041234 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK041234 Hemocue Hemoglobin 201DM Analyzing SystemHemocue, Inc. · 2004 · Recalled
- This deviceK121752 Avie Total HB Test SystemMec Dynamics Corp · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041234 | Hemocue Hemoglobin 201DM Analyzing System | Hemocue, Inc. | 2004 | 1 |
| 0 (this device) | K121752 | Avie Total HB Test System | Mec Dynamics Corp | 2013 | — |
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 GKR? 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 GKR device
- #1 K201217 HemoCue Hb 301 Systemscore 0.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K041234 | Hemocue Hemoglobin 201DM Analyzing SystemSummary page 2…s between the two test systems. Characteristic ilemoCue@ 201+ System AvieH Total Fib K041234 K121752 Sample Type Capillary and venous whole blood Capillary and veno… | 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?
- Its one ancestor has a recall.
How does its category compare?
All GKR devicesGKR System, Hemoglobin, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GKR
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · GKR
Too few GKR 510(k)s in any year since 2007 to give a median.
Recalls per year · GKR
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKR
1in 2024
MAUDE reports naming product code GKR, 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 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 16 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 1 | — | 1 | 12 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 2 | — | 1 | 43 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 19 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 9 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AvieTM Total Hb Test System is for the quantitative measurement of total hemoglobin in whole blood (capillary or venous EDTA, K2). The test system is designed for point-of-care use in primary care settings. The test system is for professional in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121752: Avie Total HB 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/K121752
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