FDA product code · General hospital

Drape, Surgical, Exempt

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

PUIClass II21 CFR 878.4370510(k) exempt0 decisions37 recalls

FDA lists PUI as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 878.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. 37 recalls name this code, 0 of them Class I.

This product code is the class II exempt counterpart of KKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State”…

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 PUI 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 · PUI

FDA has decided no PUI device since 2007.

Median 510(k) review, days · PUI

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

Recalls per year · PUI

19in 2022

2007high 19 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PUI

55in 2025

2007high 69 (2024) · low 0 (2007)2025

MAUDE reports naming product code PUI, 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	0
2016	—	0	0
2017	—	0	0
2018	—	4	9
2019	—	0	28
2020	—	0	17
2021	—	0	43
2022	—	19	47
2023	—	0	46
2024	—	0	69
2025	—	0	55
2026	—	14	—

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

Planning a device in PUI? 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 878.4370.

HMW Drape, Microscope, Ophthalmic PLY Antimicrobial Drapes HMT Drape, Patient, Ophthalmic EYX Drape, Pure Latex Sheet, With Self-Retaining…EYY Drape, Urological, Disposable MMP Cover, Barrier, Protective KKX Drape, Surgical, Antimicrobial KGW Ring (Wound Protector), Drape Retention…LRO General Surgery Tray FNW Pad, Kelly ERY Drape, Surgical, Ent NZP Sealant, Microbial

Drape, Surgical, Exempt

What has been recalled in PUI lately?

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