Product code HGM: 510(k) clearances and predicates
Product code HGM covers Novii+ Wireless Patch System. FDA lists 215 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
215 clearances on file under product code HGM. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 4 |
| 2026 so far | 2 |
Recent clearances
Newest HGM clearances in the FDA index, with applicant and decision date:
- K254036, Novii+ Wireless Patch System, applicant Datex Ohmeda, Inc., decided 2026-08-10. FDA record
- K253021, ANNE Maternal, applicant Sibel Health, Inc., decided 2026-02-26. FDA record
- K250777, Sonicaid Team3, applicant Huntleigh Healthcare , Ltd., decided 2025-09-19. FDA record
- K241882, Fetal & Maternal Monitor (F15A, F15A Air), applicant Edan Instruments, Inc., decided 2025-08-27. FDA record
- K241368, Sonicaid Team3, applicant Huntleigh Healthcare , Ltd., decided 2025-02-03. FDA record
- K241009, PeriCALM Patterns 3.0, applicant Perigen, Inc., decided 2025-01-10. FDA record
- K233440, Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341), applicant Philips Medizin Systeme Boeblingen GmbH, decided 2024-07-02. FDA record
- K231964, Novii+ Wireless Patch System, applicant Datex Ohmeda, decided 2023-12-08. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Sonicaid Team3, ANNE Maternal. Watch new HGM clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code HGM?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent HGM clearances include Novii+ Wireless Patch System.
How many 510(k) clearances use product code HGM?
215 at the time this page was generated, from openFDA records.
How do I find a predicate device under HGM?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new HGM clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.