510(k) · Cleared
ClearedFinder G6PD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baebies, Inc. · JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Cleared on Sep 14, 2022 as substantially equivalent to K024006 (Pointe Scientific, Inc.,, 2003) after an 876-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Sep 14, 2022
- Review
- 876 days
- Class
- Class II
- Product code
- JBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K024006 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK024006 G6PDH, Glucose-6-Phoshate DehydrogenasePointe Scientific, Inc., · 2003 · Recalled
- This deviceK201049 Finder G6PDBaebies, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K024006 | G6PDH, Glucose-6-Phoshate Dehydrogenase | Pointe Scientific, Inc., | 2003 | 1 |
| 0 (this device) | K201049 | Finder G6PD | Baebies, Inc. | 2022 | — |
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 JBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K024006 | G6PDH, Glucose-6-Phoshate DehydrogenaseSummary page 4…redicate Device Class Manufacturer 510(k) Device Name/Description Number II Pointe Scientific, Inc. K024006 Glucose-6-Phosphate Dehydrogenase (G6PD) Reagent… | 2003 |
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 JBF devicesJBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JBF
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JBF
Too few JBF 510(k)s in any year since 2007 to give a median.
Recalls per year · JBF
No recall names JBF since 2007.
Adverse event reports per year · JBF
4in 2023
MAUDE reports naming product code JBF, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The FINDER G6PD test is intended for semi-quantitative measurement of glucose-6-phosphate dehydrogenase in venous whole blood specimens collected in lithium heparin tubes, for the identification of G6PD deficient samples.
The FINDER G6PD test is intended to be used with the FINDER Instrument in point of care or clinical laboratory settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201049: Finder G6PD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201049
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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