FDA product code · General and plastic surgery

Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

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

PYOClass I21 CFR 880.5240510(k) exempt1 decision since 20170 recalls

FDA lists PYO as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 880.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2017. No recall names this code.

A device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin

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 and plastic surgery panel

Twenty years of PYO 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 · PYO

1in 2017

2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PYO

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

Recalls per year · PYO

No recall names PYO since 2007.

Adverse event reports per year · PYO

2in 2024

2007high 2 (2024) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	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	1	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	2
2025	0	—	0
2026	0	—	—

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

Planning a device in PYO? 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 880.5240.

FPX Strip, Adhesive, Closure, Skin KGX Tape And Bandage, Adhesive MZR Topical Approximation System

Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

What has FDA decided in PYO lately?

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