510(k) · Cleared

Cleared

Cybrex Tobramycin

K802668510(k) TraditionalCleared Nov 24, 198028-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 · LCR Fluorescent Immunoassay, Tobramycin

Cleared on Nov 24, 1980 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided: Nov 24, 1980
Review: 28 days
Class: Class II
Product code: LCR
Recalls: None
Predicates: 0

3 later devices descend from it, 2 citing it directly.

This deviceK802668 Cybrex TobramycinAbbott Laboratories · 1980
Descendant · cites it directly · 1 of its ownK964457 Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc. · 1997 · Recalled
Descendant · cites it directly · 0 of its ownK060998 QMS TobramycinSeradyn, Inc. · 2006
Descendant · 2 generations on · 0 of its ownK060853 Online TDM TobramycinRoche Diagnostics Corp. · 2006 · Recalled

Most influential descendants

Showing 3 of 3 · See all

K964457Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc. · 1997 · cites it directly1descendant
K060998QMS TobramycinSeradyn, Inc. · 2006 · cites it directly0descendants
K060853Online TDM TobramycinRoche Diagnostics Corp. · 2006 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K802668	Cybrex Tobramycin	Abbott Laboratories	1980	—
+1	K964457	Roche Cobas Ibtegra Reagent Cassettes	Roche Diagnostic Systems, Inc.	1997	2
+1	K060998	QMS Tobramycin	Seradyn, Inc.	2006	—
+2	K060853	Online TDM Tobramycin	Roche Diagnostics Corp.	2006	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2006	2	0

FIG. 1 — Lineage of K802668, 1980–2006Source: 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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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? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K964457	Roche Cobas Ibtegra Reagent Cassettes	Roche Diagnostic Systems, Inc.	1997	1
K060998	QMS Tobramycin	Seradyn, Inc.	2006	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, K964457 (Roche Diagnostic Systems, Inc., 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LCR devices

LCR Fluorescent Immunoassay, Tobramycin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LCR

FDA has decided no LCR device since 2007.

Median 510(k) review, days · LCR

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

Recalls per year · LCR

No recall names LCR since 2007.

Adverse event reports per year · LCR

1in 2024

2007high 2 (2012) · low 0 (2007)2025

MAUDE reports naming product code LCR, not matched to any one device; reports are not rates.

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	—	2
2013	—	0
2014	—	2
2015	—	0
2016	—	1
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	1
2025	—	0
2026	—	—

https://510kreport.com/device/K802668 · printed Nov 6, 2026

Cite this page

510(k) Report. “K802668: Cybrex Tobramycin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K802668

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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