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Calm Curve, Version 01.00

by Lms Medical Systems (Canada), Ltd.

510(k) K052715

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK052715 Date22 Dec 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HGM
Device Class
Class II
Regulation
21 CFR Part 884.2740
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a System, Monitoring, Perinatal as classified under regulation number 884.2740. It is intended for use in the Obstetrics/Gynecology medical specialty.

It was cleared via FDA 510(k) under K052715 on December 22, 2005, with a Special clearance type and Substantially Equivalent decision. The device is manufactured by Lms Medical Systems (Canada), Ltd. and assigned product code HGM.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CALM CURVE VERSION 01.00 device used for?

    The CALM CURVE VERSION 01.00 is a perinatal monitoring system intended for use in the obstetrics/gynecology medical specialty to monitor fetal and maternal physiological parameters during labor and delivery, as indicated by its classification under regulation 884.2740 and product code HGM.

  • How was the CALM CURVE VERSION 01.00 cleared for market release?

    The device received FDA 510(k) clearance under submission number K052715 on December 22, 2005, with a Special clearance type and a Substantially Equivalent decision, meaning it was found to be substantially equivalent to a legally marketed predicate device.

  • Who manufactures the CALM CURVE VERSION 01.00 and where is it located?

    The CALM CURVE VERSION 01.00 is manufactured by Lms Medical Systems (Canada), Ltd., located at 5252 De Maisonneuve W., #314, Montreal, QC H4A 3S5, Canada, as specified in the device’s authorization and establishment registration details.