510(k) Report

FDA product code · General hospital

Mid-Stream Collection Kit

PWZClass I21 CFR 880.67300 decisions0 recalls

0 FDA decisions. No recall names this code.

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if…

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, general hospital panel

Twenty years of PWZ 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 · PWZ

FDA has decided no PWZ device since 2007.

Median 510(k) review, days · PWZ

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

Recalls per year · PWZ

No recall names PWZ since 2007.

Adverse event reports per year · PWZ

2in 2020

2020: 2
2007high 2 (2020) · low 0 (2007)2025

MAUDE reports naming product code PWZ, 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—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—02
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — PWZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PWZ? 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 880.6730.

PWM Admission Kit (Patient Utensil)FOB BedpanFNP UrinalFNY Basin, EmesisPXF Sitz Bath Kit