FDA product code OWL: Peripheral Catheter Insertion Kit

OWL is the FDA product code for peripheral catheter insertion kit. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel. Devices under OWL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 17 recalls for OWL devices, 8 initiated in the last five years.

Definition

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.

Classification

Recalls for OWL devices

17 product recalls in 8 recall events; 8 initiated in the last five years and 7 still open. Most recent: 2026-08-10.

Frequently asked questions

What is FDA product code OWL?

OWL is the FDA product code for peripheral catheter insertion kit. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel.

What device class is OWL?

Class II, regulation 21 CFR 880.5200. Typical premarket route: 510(k) exempt.

Have OWL devices been recalled?

Yes: 17 product recalls across 8 recall events; the most recent began 2026-08-10.

Next steps

• Run an FDA pathway report with predicate devices for product code OWL
• Run a recall and safety report across every OWL manufacturer
• Watch product code OWL for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times