510(k) · Cleared

Cleared

Anti-Cytokeratin Monoclonal Antibody

K864893510(k) TraditionalCleared Jul 7, 1988570-day reviewClass II21 CFR 866.5550

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

Bd Becton Dickinson Vacutainer Systems Preanalytic · LYE Cytokeratins

Cleared on Jul 7, 1988 after a 570-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: Jul 7, 1988
Review: 570 days
Class: Class II
Product code: LYE
Recalls: None
Predicates: 0

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

This deviceK864893 Anti-Cytokeratin Monoclonal AntibodyBd Becton Dickinson Vacutainer Systems Preanalytic · 1988
Descendant · cites it directly · 0 of its ownK971905 Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone…Dako Corp. · 1997

Most influential descendants

Showing 1 of 1 · See all

K971905Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal…Dako Corp. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K864893	Anti-Cytokeratin Monoclonal Antibody	Bd Becton Dickinson Vacutainer Systems Preanalytic	1988	—
+1	K971905	Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12…	Dako Corp.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K864893, 1988–1997Source: 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 LYE? 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
K971905	Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal…	Dako Corp.	1997	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, K971905 (Dako Corp., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LYE devices

LYE Cytokeratins: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYE

FDA has decided no LYE device since 2007.

Median 510(k) review, days · LYE

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

Recalls per year · LYE

No recall names LYE since 2007.

Adverse event reports per year · LYE

No MAUDE report names LYE 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/K864893 · printed Nov 6, 2026

Cite this page

510(k) Report. “K864893: Anti-Cytokeratin Monoclonal Antibody.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K864893

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