Axsym (TM) Quinidine

K940682510(k) TraditionalCleared Jun 21, 1994131-day reviewClass II21 CFR 862.3645Recalls 4

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

Abbott Laboratories · LGI Fluorescence Polarization Immunoassay, Carbamazepine

Cleared on Jun 21, 1994 after a 131-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 4 times.

Decided: Jun 21, 1994
Review: 131 days
Class: Class II
Product code: LGI
Recalls: 4
Predicates: 0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K940682Source: FDA 510(k) database · 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 LGI? 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

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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?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 31, 2007	Not classified	Z-1185-2007	Other	Controls Out of Range/Specification .
May 31, 2007	Not classified	Z-1186-2007	Other	Controls Out of Range/Specification .
May 31, 2007	Not classified	Z-1187-2007	Other	Controls Out of Range/Specification.
May 31, 2007	Not classified	Z-1188-2007	Other	Controls Out of Range/Specification.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LGI devices

LGI Fluorescence Polarization Immunoassay, Carbamazepine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LGI

FDA has decided no LGI device since 2007.

Median 510(k) review, days · LGI

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

Recalls per year · LGI

4in 2007

2007high 4 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LGI

No MAUDE report names LGI since 2007.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	4	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

https://510kreport.com/device/K940682 · printed Nov 3, 2026

Cite this page

510(k) Report. “K940682: Axsym (TM) Quinidine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K940682

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026