Who else makes this device?

Name: Compact II
Brand: Compact II

Obstetrics & Gynecology › MonitoringTransducer, Ultrasonic, Obstetric

Compact II

Catalogue number 60132II, listed by Avante, under Transducer, Ultrasonic, Obstetric. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code HGL
Manufacturer	City	Province	Registered as	Device types
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Orantech Inc.	Shenzhen	Guangdong	Contract manufacturer	40

Record

Regulatory record for Compact II
Listed by	Avante
FDA product code	HGL
Device type	Transducer, Ultrasonic, Obstetric
Device class	Class 2
Regulation	21 CFR 884.2960
510(k)	K102140
Record published	2016-09-23
Record revised	2021-03-29 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Compact II
Catalogue number	Size	Status
60132II		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ultrasound Transducer	Edan Instruments, Inc.	4
Dopplex	Huntleigh Healthcare Ltd.	3
US Transducer	Edan Instruments, Inc.	3
Fetal & Maternal Module	Edan Instruments, Inc.	2
Toco Transducer	Edan Instruments, Inc.	2
Fetal monitor	Edan Instruments, Inc.	2
AIV	American IV Products, Inc.	1
2.20MHZ OB Probe 641-A	Parks Medical Electronics, Inc.	1
2.75 MHZ OB Probe	Parks Medical Electronics, Inc.	1
Transducer, Ultrasonic, Obstetric	Edan Instruments, Inc.	1
2.00MHZ OB Probe 641	Parks Medical Electronics, Inc.	1
2.10MHZ OB Probe 641	Parks Medical Electronics, Inc.	1

Showing 12 of 27. All products under Transducer, Ultrasonic, Obstetric

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Compact II
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Edan Diagnostics, Inc.	510(k) number	2025-10-24	Class II	Device Design	As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.	3721

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P800016	1986-01-08	TENNANT(TM) & KELMAN(TM) TYPE II	Bausch & Lomb Incorporated

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.