510(k) Report

FDA product code · Cardiovascular

Probe, Blood-Flow, Extravascular

DPTClass II21 CFR 870.2120510(k) required48 decisions since 197823 recalls

48 FDA decisions since 1978. 510(k) reviews decided 2021–2025 took a median of 245 days (half between 245 and 245). 23 recalls name this code, 0 of them Class I. The most-cited predicate is K032841, named by 6 later devices.

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 DPT 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 · DPT

1in 2024

2007: 32009: 12012: 22013: 32014: 32015: 12016: 12017: 12024: 1
2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPT

201in 2014

2007: 55 days median2013: 108 days median2014: 201 days median
2007high 201 (2014) · low 55 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DPT

22in 2024

2024: 22
2007high 22 (2024) · low 0 (2007)2026

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

Adverse event reports per year · DPT

52in 2025

2007: 52008: 12009: 32010: 32011: 32012: 12014: 52018: 32019: 12020: 32021: 132022: 462023: 212024: 1692025: 52
2007high 169 (2024) · low 0 (2013)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735505
20080—01
20091—03
20100—03
20110—03
20122—01
2013310800
2014320105
20151—00
20161—00
20171—00
20180—03
20190—01
20200—03
20210—013
20220—046
20230—021
20241—22169
20250—052
20260—0—
FIG. 1 — DPT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DPT? 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 870.2120.