510(k) · Cleared

Cleared

Axsym Tobramycin

K941614510(k) TraditionalCleared Aug 18, 1994136-day reviewClass II21 CFR 862.3900

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

Abbott Laboratories · LFW Fluorescence Polarization Immunoassay, Tobramycin

Cleared on Aug 18, 1994 after a 136-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: Aug 18, 1994
Review: 136 days
Class: Class II
Product code: LFW
Recalls: None
Predicates: 0

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

This deviceK941614 Axsym TobramycinAbbott Laboratories · 1994
Descendant · cites it directly · 0 of its ownK012312 Immulite 2000 Tobramycn, Models L2KTC2 (2002 Tests), L2KTC6 (600…Diagnostic Products Corp. · 2001

Most influential descendants

Showing 1 of 1 · See all

K012312Immulite 2000 Tobramycn, Models L2KTC2 (2002 Tests), L2KTC6 (600 Tests)Diagnostic Products Corp. · 2001 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K941614	Axsym Tobramycin	Abbott Laboratories	1994	—
+1	K012312	Immulite 2000 Tobramycn, Models L2KTC2 (2002 Tests), L2KTC6 (600 Tests)	Diagnostic Products Corp.	2001	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K941614, 1994–2001Source: 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.

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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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012312	Immulite 2000 Tobramycn, Models L2KTC2 (2002 Tests), L2KTC6 (600 Tests)	Diagnostic Products Corp.	2001	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, K012312 (Diagnostic Products Corp., 2001) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LFW devices

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

FDA decisions per year · LFW

FDA has decided no LFW device since 2007.

Median 510(k) review, days · LFW

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

Recalls per year · LFW

1in 2013

2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · LFW

No MAUDE report names LFW since 2007.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	1	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/K941614 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941614: Axsym Tobramycin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941614

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026