FDA product code · Neurology

Intracranial Pressure & Temperature Monitoring Kit

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

PSPClass II21 CFR 882.16200 decisions1 recall

0 FDA decisions. 1 recall names this code; it is not 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, neurology panel

Twenty years of PSP 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 · PSP

FDA has decided no PSP device since 2007.

Median 510(k) review, days · PSP

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

Recalls per year · PSP

1in 2022

2007high 1 (2022) · low 0 (2007)2026

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

Adverse event reports per year · PSP

2in 2019

2007high 2 (2019) · low 0 (2007)2025

MAUDE reports naming product code PSP, 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	—	0	0
2019	—	0	2
2020	—	0	0
2021	—	0	0
2022	—	1	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

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

Planning a device in PSP? 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 882.1620.

GWM Device, Monitoring, Intracranial Pressure

Intracranial Pressure & Temperature Monitoring Kit

What has been recalled in PSP lately?

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