Who else makes this device?

Name: Edwards FLO-003S Ultrasonic Blood Flow Detector Straight Probe, Box
Brand: Edwards FLO-003S Ultrasonic Blood Flow Detector Straight Probe, Box

Edwards FLO-003S Ultrasonic Blood Flow Detector Straight Probe, Box · Flowmeter, Blood, Cardiovascular → Cardiovascular

4manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

5recalls on this code

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code DPW
Manufacturer	City	Province	Registered as	Device types
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Helen of Troy Macao Limited	Macau	Guangdong	Private-label distributor	11
Dongguan Mars Medical Products Co., Ltd.	Dongguan	Guangdong	Manufacturer	9
Onbo Electronic (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	6

Record

Regulatory record for Edwards FLO-003S Ultrasonic Blood Flow Detector Straight Probe, Box
Listed by	Vascular Technology Incorporated, United States
FDA product code	DPW
Device type	Flowmeter, Blood, Cardiovascular
Device class	Class 2
Regulation	21 CFR 870.2100
Establishment	Manufacturer
510(k)	K082870
Record published	2016-09-20
Record revised	2025-06-02 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Special storage condition: Keep Dry
Distribution end date	2025-05-30

Catalogue Numbers

Catalogue numbers for Edwards FLO-003S Ultrasonic Blood Flow Detector Straight Probe, Box
Catalogue number	Size	Per pack	Status
128361		4	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Transonic	Transonic Systems, Inc.	627
SonoTT Vascular Probe	Em-Tec GmbH	12
BiDop 7 probe	Koven Technology, Inc.	8
Medistim MiraQ Cardiac System	Medistim ASA	6
Medistim MiraQ Vascular System	Medistim ASA	6
FlowMet™	Medtronic, Inc.	4
GEM Flow Coupler	Synovis Micro Companies Alliance	4
CooperSurgical®	Coopersurgical, Inc.	4
Medistim System Activation Card	Medistim ASA	3
811-BL 24V Foreign & Domestic	Parks Medical Electronics, Inc.	3
Medistim MiraQ Ultimate System	Medistim ASA	3
Dopplex	Huntleigh Healthcare Ltd.	3

Showing 12 of 154. All products under Flowmeter, Blood, Cardiovascular

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K082870	2008-10-28
K031091	2003-04-23

Recalls Naming This Product

4 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Edwards FLO-003S Ultrasonic Blood Flow Detector Straight Probe, Box
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Vascular Technology Incorporated	510(k) number	2014-05-28	Class II	Process design	Report of the product penetrating the sterile barrier; this could render the product unsterile.	164	2016-02-11
Vascular Technology Incorporated	510(k) number	2014-05-28	Class II	Process design	Report of the product penetrating the sterile barrier; this could render the product unsterile.	147	2016-02-11
Vascular Technology Incorporated	510(k) number	2014-05-28	Class II	Process design	Report of the product penetrating the sterile barrier; this could render the product unsterile.	34	2016-02-11
Vascular Technology Incorporated	510(k) number	2014-05-28	Class II	Process design	Report of the product penetrating the sterile barrier; this could render the product unsterile.	25	2016-02-11

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2018-06-19	Class II	Labeling Change Control	Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver	10 units	2020-01-30

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Edwards FLO-003S Ultrasonic Blood Flow Detector Straight Probe, Box