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
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
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
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.