510(k) Report

FDA product code · Pathology

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

NSDClass IIIPMA required0 decisions since 20060 recalls

0 FDA decisions since 2006. No recall names this code.

In vitro diagnostic test to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via fluorescence in situ hybridization (fish) in urine specimens from persons suspected of having bladder cancer. It is an adjunctive test for initial diagnosis of transitional cell carcinoma in symptomatic patients and subsequently monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

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

FIG. A — Illustration, pathology panel

Twenty years of NSD at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NSD

1in 2022

2007: 12009: 12011: 52012: 22013: 32014: 32015: 12016: 12017: 12018: 22019: 12020: 12022: 1
2007high 5 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NSD

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

Recalls per year · NSD

No recall names NSD since 2007.

Adverse event reports per year · NSD

1in 2020

2013: 12014: 12015: 22016: 12020: 1
2007high 2 (2015) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20091—00
20100—00
20115—00
20122—00
20133—01
20143—01
20151—02
20161—01
20171—00
20182—00
20191—00
20201—01
20210—00
20221—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — NSD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NSD? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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