Obstetrics and Gynecology · 510(k) · 2025
PeriCALM Patterns 3.0
PeriGen, Inc.. Cleared by FDA on 10 January 2025 under submission K241009, product code HGM (system, monitoring, perinatal). What FDA's record says, in FDA's words.
Device record · K241009
- Device. PeriCALM Patterns 3.0DEVICE
- Company. PeriGen, Inc. (IL)COMPANY
- Decision. 10 January 2025, 510(k), substantially equivalent (traditional review); received 12 April 2024DECISION
- Panel. Obstetrics and GynecologyPANEL
- Product code. HGM, System, Monitoring, PerinatalCODE
- Regulation. 21 CFR 884.2740, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
PeriCALM Patterns is intended for use to provide additional secondary information as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥32 weeks gestation for annotation and summary of the fetal heart rate recording for baseline, accelerations and decelerations and the uterine pressure recording for contractions. WARNING: Evaluation of FHR during labor and patient management decisions should not be based solely on PeriCALM Patterns annotations or summaries and should include inspection of the fetal monitor tracing and consideration of all pertinent clinical information.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1,221 reports filed against devices carrying product code HGM. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
29 September 2026 · Malfunction · Avalon Fetal Monitor FM50 · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-102049
29 September 2026 · Malfunction · Avalon Fetal Monitor FM20 · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-102053
It was reported that the Fetal/Maternal Pulse is inaccurate. The device was in use on a patient at the time of the event. There was no adverse event reported.
24 September 2026 · Malfunction · Avalon Fetal Monitor FM20 · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-102001
The customer reported that the device produced abnormal fetal heart parameter results. The device was not in use on a patient at the time of event, there was no adverse event reported.
23 September 2026 · Malfunction · Avalon Toco MP Transducer · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-101989
It was reported that the sensor has a sporadic malfunction as the values fluctuate between 0 and 127, even when the sensor is not attached. The device was in clinical use. There was no report of patient or user harm.
23 September 2026 · Malfunction · IP Perinatal Software · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-101997
Philips received a complaint on the IntelliSpace Perinatal K Small Arch indicating that that alarms on one PC were triggered a few minutes after the event occurred. There was no delay for the patient and the procedure was completed. The device was not use on a patient at time of event, there was no adverse event reported.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code HGM, in Obstetrics and Gynecology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.