De Novo · Granted

Granted

Vysis EGR1 Fish Probe Kit - SC (Specimen Characterization)

DEN130010De NovoGranted Jul 29, 2013111-day reviewClass II21 CFR 864.1870

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

Abbott Molecular, Inc. · PDO Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization

Granted on Jul 29, 2013 as a new device type through De Novo after a 111-day review. 1 later device descends from it.

Decided: Jul 29, 2013
Review: 111 days
Class: Class II
Product code: PDO
Recalls: None

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

This deviceDEN130010 Vysis EGR1 Fish Probe Kit - SC (Specimen Characterization)Abbott Molecular, Inc. · 2013
Descendant · cites it directly · 0 of its ownK131508 Vysis D7S486/Cep 7 Fish Probe KitAbbott Molecular, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all

K131508Vysis D7S486/Cep 7 Fish Probe KitAbbott Molecular, Inc. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	DEN130010	Vysis EGR1 Fish Probe Kit - SC (Specimen Characterization)	Abbott Molecular, Inc.	2013	—
+1	K131508	Vysis D7S486/Cep 7 Fish Probe Kit	Abbott Molecular, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of DEN130010, 2013–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA De Novo 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 PDO? 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

Does it have a predicate?

De Novo decisions do not claim a predicate device.

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
K131508	Vysis D7S486/Cep 7 Fish Probe Kit	Abbott Molecular, Inc.	2013	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, K131508 (Abbott Molecular, Inc., 2013) has gone furthest, with 0 descendants of its own.

How does its category compare?

All PDO devices

PDO Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · PDO

1in 2013

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PDO

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

Recalls per year · PDO

No recall names PDO since 2007.

Adverse event reports per year · PDO

No MAUDE report names PDO since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	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/DEN130010 · printed Nov 4, 2026

Cite this page

510(k) Report. “DEN130010: Vysis EGR1 Fish Probe Kit - SC (Specimen Characterization).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN130010

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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