HGMClass II
System, Monitoring, Perinatal
21 CFR 884.2740 / Obstetrics/Gynecology
HGM is the FDA product code for System, Monitoring, Perinatal, a class II device type, regulated under 21 CFR 884.2740. As of , FDA records hold 215 510(k) clearances under this code, the most recent dated , and 28 recalls.
Classification record
- Product code
- HGM
- Device name
- System, Monitoring, Perinatal
- Regulation
- 21 CFR 884.2740
- Device class
- Class II
- Review panel
- Obstetrics/Gynecology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 215
- Ingested recalls
- 28
Clearances, product code HGM
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 3 |
| 1977 | 9 |
| 1978 | 4 |
| 1979 | 7 |
| 1980 | 2 |
| 1981 | 3 |
| 1982 | 6 |
| 1983 | 8 |
| 1984 | 3 |
| 1985 | 7 |
| 1986 | 7 |
| 1987 | 4 |
| 1988 | 2 |
| 1989 | 7 |
| 1990 | 5 |
| 1991 | 7 |
| 1992 | 3 |
| 1993 | 3 |
| 1994 | 5 |
| 1995 | 3 |
| 1996 | 4 |
| 1997 | 7 |
| 1998 | 2 |
| 1999 | 4 |
| 2000 | 6 |
| 2001 | 8 |
| 2002 | 4 |
| 2003 | 5 |
| 2004 | 2 |
| 2005 | 10 |
| 2006 | 4 |
| 2007 | 3 |
| 2008 | 4 |
| 2009 | 4 |
| 2010 | 4 |
| 2011 | 13 |
| 2012 | 4 |
| 2013 | 2 |
| 2014 | 4 |
| 2015 | 5 |
| 2016 | 1 |
| 2017 | 3 |
| 2018 | 3 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 4 |
| 2026 | 2 |
Applicants with the most clearances
Product code HGM| Applicant | Clearances |
|---|---|
| GE Medical Systems Information Technologies, Inc. | 29 |
| Hewlett-Packard Co. | 13 |
| Edan Instruments, Inc. | 12 |
| Huntleigh Healthcare Ltd. | 11 |
| Advantage Medical Systems, Inc. | 9 |
| Philips Medizin Systeme Boeblingen GmbH | 7 |
| Roche Medical Electronics, Inc. | 7 |
| Analogic Corp. | 5 |
| Bistos co., Ltd. | 5 |
| GE Healthcare | 5 |
Companies listing this code with FDA
Companies whose registered establishments list this code- AccuMED Corp.
- Advanced Instrumentations, Inc.
- AirStrip Technologies, Inc.
- American I.V. Products, Inc.
- Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
- Amphenol Medical Technologies (Dongguan) Co., Ltd.
- B'Orze Inc
- Bionet Co., Ltd.
- Bistos co., Ltd.
- Cerner Corporation
- Cetro America
- China Qingdao Bright Medical Manufacturing Co.,Ltd.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.