FDA product code · Obstetrics/Gynecology
HGMSystem, Monitoring, Perinatal
Product code HGM covers System, Monitoring, Perinatal, a Class II device regulated under 21 CFR 884.2740. FDA has cleared 214 devices in this code, 3 of them in the last 12 months. Median review time across the 214 most recent decisions is 92 days. openFDA lists 28 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 884.2740
- Review panel
- Obstetrics/Gynecology
- Clearances
- 214
What is happening in HGM right now?
HGM (System, Monitoring, Perinatal) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2522-2026, Z-2523-2026, Z-1140-2026, Z-1141-2026, Z-1151-2026). 1 first-time filer in the last 12 months, Sibel Health, Inc (K253021). The code is crowded, scoring 68 of 100 — 89 companies hold a clearance here and 3 arrived in the last 12 months (HGM:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2522-2026, Z-2523-2026, Z-1140-2026, Z-1141-2026, Z-1151-2026 |
| New entrant | Worth knowing | K253021 |
| Crowding | Context | HGM:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in HGM?
FDA has cleared 214 devices under product code HGM since the 510(k) programme began in 1976, 3 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253021 | ANNE Maternal | Sibel Health, Inc. | |
| K250777 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | |
| K241368 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | |
| K241009 | PeriCALM Patterns 3.0 | Perigen, Inc. | |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) | Philips Medizin Systeme Boeblingen GmbH | |
| K231964 | Novii+ Wireless Patch System | Datex Ohmeda | |
| K222327 | Bloomlife MFM-Pro | Bloom Technologies NV | |
| K220732 | Mural Perinatal Surveillance | Ge Medical Systems Information Technologies, Inc. | |
| K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | Huntleigh Healthcare Limited |
How long does FDA review take for HGM?
The median FDA review time for HGM is 92 days, measured across the 214 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in HGM?
openFDA lists 28 recall records against product code HGM. A recall record covers one firm's corrective action and may span many device lots.
Z-2522-2026Open, ClassifiedPhilips North America LLC
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Z-2523-2026Open, ClassifiedPhilips North America LLC
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Z-1140-2026Open, ClassifiedEdan Diagnostics
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.
Z-1141-2026Open, ClassifiedEdan Diagnostics
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.
Z-1151-2026Open, ClassifiedEdan Diagnostics
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.
Showing the 5 most recently initiated of 28. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for HGM?
MAUDE holds 350 adverse-event reports naming product code HGM, 84 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in HGM unusual?
Every month with enough history behind it falls inside HGM's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 4 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 53 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 4 | 0–46 | Within expected (0–46) | |
| 3 | 0–35 | Within expected (0–35) | |
| 5 | 0–36 | Within expected (0–36) | |
| 11 | 0–35 | Within expected (0–35) | |
| 7 | 0–33 | Within expected (0–33) | |
| 3 | 0–33 | Within expected (0–33) | |
| 12 | 0–50 | Within expected (0–50) | |
| 7 | 0–38 | Within expected (0–38) | |
| 11 | 0–40 | Within expected (0–40) | |
| 13 | 0–40 | Within expected (0–40) | |
| 12 | 0–38 | Within expected (0–38) | |
| 9 | 1–21 | Within expected (1–21) | |
| 11 | 4–20 | Within expected (4–20) | |
| 13 | 3–16 | Within expected (3–16) | |
| 8 | 5–18 | Within expected (5–18) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in HGM.
Who has entered HGM in the last year?
One company filed in HGM for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Sibel Health, Inc. | K253021 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in HGM?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in HGM?
Across the 214 most recent decisions, these applicants filed most often in HGM.
| Applicant | Recent clearances |
|---|---|
| Ge Medical Systems Information Technologies | 28 |
| Edan Instruments, Inc. | 12 |
| Hewlett-Packard Co. | 11 |
| Advantage Medical Systems, Inc. | 9 |
| Philips Medizin Systeme Boeblingen GmbH | 7 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in HGM file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| GE Medical Systems Information Technologies, Inc. | 29 | 2 |
| Hewlett-Packard GmbH | 13 | 2 |
| Huntleigh Healthcare Ltd. | 11 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch HGM
Get an email the morning anything changes in HGM — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.