510(k) · Cleared

Cleared

Dehydrogenose, Glucose Phosphate

K790211510(k) TraditionalCleared Mar 15, 197943-day reviewClass II21 CFR 864.7360

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sigma Chemical Co. · JBL Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative

Cleared on Mar 15, 1979 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Mar 15, 1979
Review: 43 days
Class: Class II
Product code: JBL
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK790211 Dehydrogenose, Glucose PhosphateSigma Chemical Co. · 1979
Descendant · cites it directly · 0 of its ownK990957 Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13KAstoria-Pacific, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all

K990957Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13KAstoria-Pacific, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K790211	Dehydrogenose, Glucose Phosphate	Sigma Chemical Co.	1979	—
+1	K990957	Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13K	Astoria-Pacific, Inc.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K790211, 1979–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JBL? 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

Get a 510(k) 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	Applicant	Decided	Descendants
K990957	Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13K	Astoria-Pacific, Inc.	1999	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, K990957 (Astoria-Pacific, Inc., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JBL devices

JBL Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JBL

FDA has decided no JBL device since 2007.

Median 510(k) review, days · JBL

Too few JBL 510(k)s in any year since 2007 to give a median.

Recalls per year · JBL

No recall names JBL since 2007.

Adverse event reports per year · JBL

No MAUDE report names JBL since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K790211 · printed Nov 4, 2026

Cite this page

510(k) Report. “K790211: Dehydrogenose, Glucose Phosphate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K790211

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