Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device flowmeter, blood, cardiovascular
Product CodeDPW
Regulation Number 870.2100
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
DELTEX MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 4
EM-TEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
FLOSONICS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
  1.  K222242  FloPatch FP120
  2.  K223843  FloPatch FP120
FLOSONICS MEDICAL (R/A 1929803 ONTARIO CORP.)
  SUBSTANTIALLY EQUIVALENT 2
HUNTLEIGH HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
KOVEN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
LASER ASSOCIATED SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDI-STIM ASA
  SUBSTANTIALLY EQUIVALENT 1
MOOR INSTRUMENTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
OR-NIM MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
PERIMED AB
  SUBSTANTIALLY EQUIVALENT 1
REMINGTON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
RFPI
  SUBSTANTIALLY EQUIVALENT 1
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRANSONIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VASAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 8 8
2015 12 12
2016 1 1
2017 2 2
2019 3 3
2020 4 4
2021 6 6
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 14 14
Output Problem 5 5
Difficult to Open or Close 3 3
Break 3 3
Pumping Stopped 3 3
Defective Device 3 3
Out-Of-Box Failure 2 2
Electrical /Electronic Property Problem 2 2
Device Operates Differently Than Expected 2 2
Insufficient Information 2 2
Noise, Audible 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Sensing Problem 1 1
Improper Flow or Infusion 1 1
Inappropriate or Unexpected Reset 1 1
Leak/Splash 1 1
Failure to Power Up 1 1
Crack 1 1
Disconnection 1 1
Device Alarm System 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 14 14
No Patient Involvement 8 8
No Clinical Signs, Symptoms or Conditions 7 7
Insufficient Information 4 4
No Consequences Or Impact To Patient 4 4
No Information 2 2
Aneurysm 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II May-10-2016
2 Baxter Healthcare Corporation II Jul-20-2023
3 Baxter Healthcare Corporation II Jul-29-2014
4 Escalon Medical Corp II Oct-22-2010
5 Medistim Asa II Feb-26-2018
6 Parks Medical Electronics, Inc II Dec-10-2012
7 Transonic Systems Inc II Sep-03-2015
8 Vascular Technology, Inc. II Sep-12-2018
9 Vascular Technology, Inc. II Jul-07-2014
-
-