FDA Product Code DPT: Probe, Blood-flow, Extravascular
Leading manufacturers include Hewlett-Packard Co., Medtronic, Inc. and Rwd Life Science Co., Ltd..
48
Total
48
Cleared
183d
Avg days
1978
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Probe, Blood-flow, Extravascular Devices (Product Code DPT)
48 devices
Cleared
May 28, 2024
Laser Speckle Imaging System (RFLSI CZW)
Rwd Life Science Co., Ltd.
General & Plastic Surgery
245d
Cleared
May 30, 2014
BIO-PROBE DISPOSABLE INSERT WITH
Medtronic, Inc.
Cardiovascular
269d
Cleared
Apr 10, 2014
BIO-PROBE TRANSDUCER (ADULT)
Medtronic, Inc.
Cardiovascular
111d
Cleared
Aug 16, 1994
TRANSTAR PRESSURE TRANSDUCER
Medex, Inc.
Cardiovascular
90d
Cleared
Nov 07, 1991
TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY
Hewlett-Packard Co.
Radiology
161d
Cleared
Mar 15, 1991
SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM
Hewlett-Packard Co.
Cardiovascular
81d
Cleared
Dec 03, 1990
KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM
Kontron Instruments, Inc.
Cardiovascular
389d
Cleared
Feb 07, 1990
HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM
Hewlett-Packard Co.
Cardiovascular
90d
Cleared
Jun 01, 1988
APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300
General Electric Co.
Cardiovascular
292d
Cleared
Jun 01, 1988
ACCUCOM 2
Datascope Corp.
Cardiovascular
232d
Cleared
Apr 29, 1988
SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM
Toshiba Medical Systems
Cardiovascular
129d
Cleared
Feb 19, 1988
HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR
Advanced Technology Laboratories, Inc.
Cardiovascular
245d
Cleared
Jun 02, 1986
INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER
NuMED, Inc.
Cardiovascular
140d
About Product Code DPT - Regulatory Context
510(k) Submission Activity
48 total 510(k) submissions under product code DPT since 1978, with 48 receiving FDA clearance (average review time: 183 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.