510(k) Report

FDA product code · Cardiovascular

Stripper, Vein, External

DWQClass II21 CFR 870.4885510(k) required8 decisions since 19811 recall

8 FDA decisions since 1981. 510(k) reviews decided 2021–2025 took a median of 202 days (half between 202 and 202). 1 recall names this code; it is not Class I. The most-cited predicate is K032387, named by 1 later device.

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, cardiovascular panel

Twenty years of DWQ 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 · DWQ

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWQ

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

Recalls per year · DWQ

No recall names DWQ since 2007.

Adverse event reports per year · DWQ

5in 2025

2008: 32009: 12010: 22011: 12014: 12017: 72018: 362019: 292020: 52023: 12024: 42025: 5
2007high 36 (2018) · low 0 (2007)2025

MAUDE reports naming product code DWQ, 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
20070—00
20080—03
20090—01
20100—02
20110—01
20120—00
20130—00
20140—01
20150—00
20160—00
20170—07
20180—036
20190—029
20200—05
20210—00
20221—00
20230—01
20240—04
20250—05
20260—0—
FIG. 1 — DWQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DWQ? 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 870.4885.