510(k) · Cleared
ClearedCapillarys Neonat HB (PN 2006)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sebia · GKA Abnormal Hemoglobin Quantitation
Cleared on Feb 22, 2010 after a 297-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Feb 22, 2010
- Review
- 297 days
- Class
- Class II
- Product code
- GKA
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK091283 Capillarys Neonat HB (PN 2006)Sebia · 2010
- Descendant · cites it directly · 0 of its ownK232027 CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentSebia · 2024
Most influential descendants
Showing 1 of 1 · See all- K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentSebia · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091283 | Capillarys Neonat HB (PN 2006) | Sebia | 2010 | — |
| +1 | K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | Sebia | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | 2024 | 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, K232027 (Sebia, 2024) 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. 2010, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The CAPILLARYS NEONAT Hb* kit Is designed for the separation of the normal hemoglobins (F and A) in. blood sariiples from human. new-borne, and for the detection of the major hemoglobin variants (S,C, E, 0 and BDe~s), by electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 System. The CAPILLARYS NEONAT Hb kit is designed for laboratory use. The CAPILILARYS 2 Is artautomnated~anaiyzer which perfotms: a complete hemoglobin profile for the…
Read the full statement (222 words)
The CAPILLARYS NEONAT Hb* kit Is designed for the separation of the normal hemoglobins (F and A) in. blood sariiples from human. new-borne, and for the detection of the major hemoglobin variants (S,C, E, 0 and BDe~s), by electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 System. The CAPILLARYS NEONAT Hb kit is designed for laboratory use.
The CAPILILARYS 2 Is artautomnated~anaiyzer which perfotms: a complete hemoglobin profile for the qualitative analysis of hemogloblns; The assay is performed on the hemolysate of whole blood samples previously collected on filter paper.
The Hb AF Control Isdesigned:
-for the migration control before starting a new analysis sequence and for the qualitative quality control, for human hemoglobins A and F with the SEBIA CAPILLARYS NEONAT Hb electrophoresls procedure used with the CAPILLARYS 2system, and,
- for the quantitative quality control for detection of the human hemoglobins A, Fand A2 with the SEBIA electrophoresis procedures : HYDRAGEL HEMOGLOBIN(E) used with the HYDRASYS system, CAPILLARYS HEMOGLOBIN(E) used with the CAPILLARYS system and MINICAP HEMOGLOBIN(E) used with the MINICAP system.
The Hb AFR Control Is designed for laboratory use. It should be used (wilth Its bar code label for the CAPILLARYS and MIN ICAP procedures) like a normal human blood.
The values obtained must fall within the range provided with each batch of Hb AF Control.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K091283 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091283: Capillarys Neonat HB (PN 2006).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091283
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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