Centricity Perinatal
MD CPN 6.99 Medical Device
6manufacturers in China registered for this device type
1catalogue number
29510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Luen Hing Textile -Shangyu Manufacturing(ZHONG Shan) Co Ltd | Zhongshan | Guangdong | Contract manufacturer | 2 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| China Qingdao Bright Medical Manufacturing Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 8 |
Record
| Listed by | GE Medical Systems Information Technologies, Inc., United States |
|---|---|
| FDA product code | HGM |
| Device type | System, Monitoring, Perinatal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2740 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K111614 |
| Record published | 2022-05-30 |
| Record revised | 2025-12-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6.99 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R&D Batteries, Inc. | R & D Batteries, Inc. | 137 |
| Sonicaid | Huntleigh Healthcare Ltd. | 39 |
| Obix | Huntleigh Healthcare Ltd. | 33 |
| Ameritus Transducer | Kentec Medical, LLC | 28 |
| Fetal Monitor Remote Display | Clinicomp Intl., Inc. | 18 |
| Tenacore | Tenacore LLC | 11 |
| FetaLink | Cerner Corporation | 9 |
| PeriWatch Vigilance® HUB™ | PeriGen Solutions Ltd. | 9 |
| Dopplex | Huntleigh Healthcare Ltd. | 9 |
| Mini Telemetry System | Wipro GE Healthcare Private Ltd. | 8 |
| Natus Neurology | Natus Neurology Incorporated | 8 |
| Fetal & maternal monitor | Edan Instruments, Inc. | 8 |
Showing 12 of 117. All products under System, Monitoring, Perinatal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220732 | 2022-06-23 |
| K050583 | 2005-06-21 |
| K032252 | 2003-08-21 |
| K021135 | 2002-05-09 |
| K012718 | 2001-11-13 |
| K993751 | 2000-02-02 |
| K964770 | 1997-02-21 |
| K955559 | 1996-03-05 |
| K934959 | 1994-08-15 |
| K932077 | 1994-03-31 |
| K920376 | 1992-04-27 |
| K910260 | 1991-03-15 |
| K905295 | 1991-02-19 |
| K904358 | 1990-10-05 |
| K895045 | 1989-11-06 |
| K894958 | 1989-11-03 |
| K891595 | 1989-06-12 |
| K882966 | 1988-10-05 |
| K880419 | 1988-06-10 |
| K852608 | 1985-09-27 |
| K852076 | 1985-07-05 |
| K851252 | 1985-05-22 |
| K843918 | 1984-12-17 |
| K843385 | 1984-11-29 |
| K841477 | 1984-05-14 |
| K831852 | 1983-08-11 |
| K790139 | 1979-02-16 |
| K780176 | 1978-03-02 |
| K780177 | 1978-03-02 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Healthcare GmbH | 510(k) number | 2013-03-11 | Class II | Software design | 1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count of Patient slots in use which may lead to an inability to access the patient roster. The user is temporarily unable to review or edit form and | 1,132 units | 2016-06-10 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2003-05-21 | Not classified | Other | The 2120 Main Board on device lacks required external safety ‘watchdog’ circuit. | 170 | 2003-10-27 |
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.