FDA product code · General hospital

Catheter Repair Kit

Name: FDA decisions, review times, recalls and adverse event reports for product code PWR
Creator: 510(k) Report

PWRClass II21 CFR 880.59700 decisions1 recall

0 FDA decisions. 1 recall names this code; it is Class I.

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 PWR 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 · PWR

FDA has decided no PWR device since 2007.

Median 510(k) review, days · PWR

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

Recalls per year · PWR

1so far in 2026, the most since 2007

2007high 1 (2026) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · PWR

No MAUDE report names PWR since 2007.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	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	—	1 (1)	—

FIG. 1 — PWR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PWR? 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

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Other codes under 21 CFR 880.5970.

OKC Implanted Subcutaneous Securement Catheter LJS Catheter, Intravascular, Therapeutic…PZW Catheter Access Cover, Tamper-Resistant OMF Percutaneous, Implanted, Long-Term…ODY Tunneled Catheter Remover

Catheter Repair Kit

What has been recalled in PWR lately?

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