510(k) · Cleared

Cleared

ABL80 FLEX and ABL80 FLEX CO-OX

K151639510(k) TraditionalCleared Dec 7, 2015172-day reviewClass II21 CFR 862.1345

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

Sendx Medical, Inc. · CGA Glucose Oxidase, Glucose

Cleared on Dec 7, 2015 as substantially equivalent to K043218 (Radiometer Medical Aps, 2005) after a 172-day review. Its family tree reaches back 6 generations to 1986.

Decided: Dec 7, 2015
Review: 172 days
Class: Class II
Product code: CGA
Recalls: None
Predicates: 1

Its longest line of descent runs back 6 generations to K861087 (1986). 17 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 6 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
5 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
4 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
3 generations backK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
2 generations backK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
1 generation backK043218 ABL800 Flex with Flexq Module, Model ABL8XXRadiometer Medical Aps · 2005 · Recalled
This deviceK151639 ABL80 FLEX and ABL80 FLEX CO-OXSendx Medical, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K861087	Avl Model 983 Electrolyte Analyzer	Avl Scientific Corp.	1986	—
−5	K961458	Avl 9180 Electrolyte Analyzer	Avl Scientific Corp.	1996	1
−4	K972673	Avl 9181 Electrolyte Analyzer	Avl Scientific Corp.	1997	7
−3	K992859	ABL700 Series Analyzer with Autocheck Module	Radiometer America, Inc.	2000	4
−2	K041874	ABL800 Flex	Radiometer Medical Aps	2004	22
−1	K043218	ABL800 Flex with Flexq Module, Model ABL8XX	Radiometer Medical Aps	2005	3
0 (this device)	K151639	ABL80 FLEX and ABL80 FLEX CO-OX	Sendx Medical, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1987	1	0
1992	1	0
1995	1	0
1996	3	0
1997	1	0
1998	2	0
2000	1	0

FIG. 1 — Lineage of K151639, 1986–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 CGA? 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 CGA device

#1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K043218	ABL800 Flex with Flexq Module, Model ABL8XX Summary page 6 …ended for use in a laboratory environment, near patient or point-of-care setting. For in vitro diagnostic use. 4. Predicate device: ABL800 FLEX analyzer (K043218) Substantial Equivalence The modified ABL80 FLEX and ABL80 FLEX CO-OX analyzers are substantially equivalent in Intended Use, fun…	Radiometer Medical Aps	2005	3

Also cleared against K043218: 2 other devices →

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?

The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
10 of the 17 ancestors have a recall of any class.
2 other devices also cite its predicate K043218.

How does its category compare?

All CGA devices

CGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · CGA

2in 2024

2007high 10 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGA

249in 2023

2007high 441 (2013) · low 56 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CGA

3in 2023

2007high 6 (2010) · low 0 (2012)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · CGA

59in 2025

2007high 1,141 (2023) · low 29 (2007)2025

MAUDE reports naming product code CGA, 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	7	122	2	29
2008	6	56	2	37
2009	10	155	4	75
2010	8	122	6	172
2011	9	217	3	423
2012	10	123	0	233
2013	3	441	3	172
2014	5	265	2	122
2015	4	150	6 (2)	155
2016	4	157	2	36
2017	2	—	0	92
2018	2	—	0	69
2019	2	—	1	116
2020	2	—	0	68
2021	1	—	0	48
2022	1	—	0	272
2023	4	249	3	1,141
2024	2	—	0	266
2025	0	—	0	59
2026	1	—	0	—

What is it indicated for?

The ABL80 FLEX analyzer is a portable, automated analyzer that measures glucose, in whole blood. The ABL80 FLEX analyzer system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

For in vitro diagnostic use.

The ABL80 FLEX CO-OX analyzer is a portable, automated analyzer that measures glucose, in whole blood. The ABL80 FLEX CO-OX analyzer system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

For in vitro diagnostic use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K151639 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151639: ABL80 FLEX and ABL80 FLEX CO-OX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151639

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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