510(k) Report

FDA product code · Radiology

Diagnostic Ultrasonic Transducer, Robotic

OQQClass II21 CFR 892.1570510(k) required1 decision since 20100 recalls

1 FDA decision since 2010. No recall names this code. The most-cited predicate is K092164, named by 2 later devices.

Diagnostic ultrasonic imaging or monitoring.

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, radiology panel

Twenty years of OQQ 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 · OQQ

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OQQ

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

Recalls per year · OQQ

No recall names OQQ since 2007.

Adverse event reports per year · OQQ

No MAUDE report names OQQ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OQQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

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

See the 510(k) Report

Related product codes

Other codes under 21 CFR 892.1570.