FDA product code · Cardiovascular

Syringe, Balloon Inflation, Exempt

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

PTMClass II21 CFR 870.1650510(k) exempt0 decisions4 recalls

FDA lists PTM as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 870.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. 4 recalls name this code, 0 of them Class I.

This product code is the class II exempt counterpart of MAV, 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 870.9 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, cardiovascular panel

Twenty years of PTM 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 · PTM

FDA has decided no PTM device since 2007.

Median 510(k) review, days · PTM

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

Recalls per year · PTM

4in 2024

2007high 4 (2024) · low 0 (2007)2026

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

Adverse event reports per year · PTM

25in 2025

2007high 25 (2025) · low 0 (2007)2025

MAUDE reports naming product code PTM, 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	0
2020	—	0	1
2021	—	0	1
2022	—	0	0
2023	—	0	3
2024	—	4	0
2025	—	0	25
2026	—	0	—

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

Planning a device in PTM? 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 870.1650.

OER Angioscopic Valvulotome Kit OEQ Angiography/Angioplasty Kit NKU Injector And Syringe, Angiographic, Balloon…MAV Syringe, Balloon Inflation DXT Injector And Syringe, Angiographic OFH Digital Angiography Tray IZQ Injector, Contrast Medium, Automatic NKP Injector, Contrast Medium, Automatic…NKT Injector And Syringe, Angiographic, Reprocessed

Syringe, Balloon Inflation, Exempt

What has been recalled in PTM lately?

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