Chrysalis Intelligence · Product Codes · HGM

HGM · System, Monitoring, Perinatal

Obstetrics/Gynecology · 11 clearances · 8 unique sponsors

Device class
Class II
Regulation 884.2740
Total clearances
11
2020-06-24 → 2026-08-10
Last 12 months
3
Unique sponsors
8
Medical specialty
Obstetrics/Gynecology
Review panel
OB
Regulation number
884.2740
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Huntleigh Healthcare Limited 3 1 2025-09-19
Datex Ohmeda 2 1 2026-08-10
Sibel Health, Inc. 1 1 2026-02-26
Bloom Technologies NV 1 0 2023-02-13
Perigen, Inc. 1 0 2025-01-10
Edan Instruments, Inc. 1 0 2025-08-27
Ge Medical Systems Information Technologies, Inc. 1 0 2022-06-23
Philips Medizin Systeme Boeblingen GmbH 1 0 2024-07-02
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
59050 CPT Medium Fetal monitoring codes; perinatal monitoring system includes hardware/software
59051 CPT Medium Fetal monitoring with electronic signals and recordings
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-10 K254036 Datex Ohmeda, Inc. Novii+ Wireless Patch System
2026-02-26 K253021 Sibel Health, Inc. ANNE Maternal
2025-09-19 K250777 Huntleigh Healthcare , Ltd. Sonicaid Team3
2025-08-27 K241882 Edan Instruments, Inc. Fetal & Maternal Monitor (F15A, F15A Air)
2025-02-03 K241368 Huntleigh Healthcare , Ltd. Sonicaid Team3
2025-01-10 K241009 Perigen, Inc. PeriCALM Patterns 3.0
2024-07-02 K233440 Philips Medizin Systeme Boeblingen GmbH Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
2023-12-08 K231964 Datex Ohmeda Novii+ Wireless Patch System
2023-02-13 K222327 Bloom Technologies NV Bloomlife MFM-Pro
2022-06-23 K220732 Ge Medical Systems Information Technologies, Inc. Mural Perinatal Surveillance
2020-06-24 K200975 Huntleigh Healthcare Limited Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum