510(k) · Cleared
Recalled · 2004Resolve-HB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isolab, Inc. · GKA Abnormal Hemoglobin Quantitation
Cleared on Feb 4, 1984 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Feb 4, 1984
- Review
- 31 days
- Class
- Class II
- Product code
- GKA
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK840011 Resolve-HBIsolab, Inc. · 1984
- Descendant · cites it directly · 0 of its ownK954048 Variant Hemoglobinopathy ProgramBio-Rad · 1995
Most influential descendants
Showing 1 of 1 · See all- K954048Variant Hemoglobinopathy ProgramBio-Rad · 1995 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K840011 | Resolve-HB | Isolab, Inc. | 1984 | — |
| +1 | K954048 | Variant Hemoglobinopathy Program | Bio-Rad | 1995 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKA? 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 GKA device
- #1 K232027 CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrumentscore 7.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K954048 | Variant Hemoglobinopathy Program | 1995 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2004 | Not classified | Z-0047-05 | Other | The product insert for the test kits is incorrect with regard to the acceptable storage temperature for the Agarose IEF gel component. The kit and IEF gel labels indicate the correct storage temperature of 2-8 degrees C. The product… |
| Jun 29, 2004 | Not classified | Z-1158-04 | Other | Hemoglobin Test Kit Catholyte Solution generating false positive results, were distributed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K954048 (Bio-Rad, 1995) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GKA devicesGKA Abnormal Hemoglobin Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GKA
Too few GKA 510(k)s in any year since 2007 to give a median.
Recalls per year · GKA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKA
2in 2013
MAUDE reports naming product code GKA, 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 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 2 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 5 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K840011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K840011: Resolve-HB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K840011
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026