FDA product code · General hospital

Peripheral Catheter Insertion Kit

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

OWLClass II21 CFR 880.52000 decisions7 recalls

0 FDA decisions. 7 recalls name this code, 1 of them Class I.

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

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 OWL 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 · OWL

FDA has decided no OWL device since 2007.

Median 510(k) review, days · OWL

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

Recalls per year · OWL

4in 2022

2007high 4 (2022) · low 0 (2007)2026

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

Adverse event reports per year · OWL

1in 2025

2007high 6 (2023) · low 0 (2007)2025

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

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	2
2016	—	0	0
2017	—	0	2
2018	—	0	0
2019	—	0	2
2020	—	0	4
2021	—	0	4
2022	—	4	0
2023	—	0	6
2024	—	0	2
2025	—	0	1
2026	—	3 (1)	—

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

Planning a device in OWL? 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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Peripheral Catheter Insertion Kit

What has been recalled in OWL lately?

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