Cleared Traditional

K980719 - CALM

K980719 is an FDA 510(k) clearance for CALM, manufactured by Lms Medical Systems , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K980719 · Lms Medical Systems , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
157d
Days
Class 2
Risk

K980719 is an FDA 510(k) clearance for the CALM. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Lms Medical Systems , Ltd. (Montreal, Qc, CA). The FDA issued a Cleared decision on July 31, 1998 after a review of 157 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lms Medical Systems , Ltd. devices

FDA 510(k) Submission Details - K980719

510(k) Number K980719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1998
Decision Date July 31, 1998
Days to Decision 157 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 160d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGM Device Classification - Class 2, Special Controls

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 140
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K980719.
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
K991739 · General Electric Medical Systems Information Techn · Aug 1999
FETALGARD 3000 FETAL MONITOR
K983395 · Analogic Corp. · Aug 1999
WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM
K974248 · Air-Shields, Inc. · Oct 1998
BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM
K965008 · Spacelabs Medical, Inc. · Dec 1997
HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM
K970456 · Hewlett-Packard GmbH · Oct 1997
BABY DOPPLEX (3000)
K963711 · Huntleigh Healthcare, Inc. · Sep 1997