DPT · Class II · 21 CFR 870.2120

FDA Product Code DPT: Probe, Blood-flow, Extravascular

Leading manufacturers include Moor Instruments, Ltd., Hewlett-Packard Co. and Vasamedics, LLC.

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
1–24 of 48
Cleared May 28, 2024
Laser Speckle Imaging System (RFLSI CZW)
K233076
Rwd Life Science Co., Ltd.
General & Plastic Surgery · 245d
Cleared Aug 17, 2017
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
K163339
Spectralmd, Inc.
Cardiovascular · 262d
Cleared May 12, 2016
moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager
K152749
Moor Instruments, Ltd.
Cardiovascular · 232d
Cleared Jan 22, 2015
Deltex Medical KDP72 Doppler Probe
K142932
Deltex Medical Limited
Cardiovascular · 105d
Cleared May 30, 2014
BIO-PROBE DISPOSABLE INSERT WITH
K132730
Medtronic, Inc.
Cardiovascular · 269d
Cleared Apr 10, 2014
BIO-PROBE TRANSDUCER (ADULT)
K133903
Medtronic, Inc.
Cardiovascular · 111d
Cleared Jan 29, 2014
MOORLDLS-BI LASER DOPPLER BURNS IMAGER
K132163
Moor Instruments, Ltd.
Cardiovascular · 201d
Cleared Apr 18, 2013
DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM
K124049
Spectralmd, Inc.
Cardiovascular · 108d
Cleared Feb 07, 2013
AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN
K123216
Aimago SA
Cardiovascular · 115d
Cleared Jan 03, 2013
MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
K122943
Moor Instruments, Ltd.
Cardiovascular · 101d
Cleared Aug 10, 2012
AIMAGO EASYLDI MICROCIRCULATION CAMERA
K121429
Aimago SA
Cardiovascular · 88d
Cleared Jul 03, 2012
PERICAM PSI
K120884
Perimed AB
Cardiovascular · 102d
Cleared Mar 27, 2007
MOORLD12-B1 LASER DOPPLER BURNS IMAGER
K060976
Moor Instruments, Ltd.
Cardiovascular · 351d
Cleared Jan 25, 2007
MOORFLPI FULL-FIELD LASER PERFUSION IMAGER
K063586
Moor Instruments, Ltd.
Cardiovascular · 55d
Cleared Jan 19, 2007
MOORLDLS LASER DOPPLER LINE SCANNER
K063561
Moor Instruments, Ltd.
Cardiovascular · 53d
Cleared Mar 08, 2006
DP240 240 HOUR DOPPLER PROBE
K052989
Deltex Medical
Cardiovascular · 135d
Cleared Sep 14, 2001
TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
K012747
Medtronic Perfusion Systems
Cardiovascular · 29d
Cleared Apr 30, 1998
MOOORLDI LASER DOPPLER IMAGER
K980383
Moor Instruments, Ltd.
Cardiovascular · 87d
Cleared Apr 08, 1998
ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
K963703
International Biophysics Corp.
Cardiovascular · 569d
Cleared Apr 09, 1997
VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT
K962700
Vasamedics, LLC
Cardiovascular · 271d
Cleared Oct 11, 1996
TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT
K961368
Vasamedics, LLC
Cardiovascular · 185d
Cleared Mar 21, 1996
LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433
K951832
Vasamedics, LLC
Cardiovascular · 336d
Cleared Aug 16, 1994
TRANSTAR PRESSURE TRANSDUCER
K942377
Medex, Inc.
Cardiovascular · 90d
Cleared Nov 07, 1991
TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY
K912404
Hewlett-Packard Co.
Radiology · 161d

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.