Quantitative Sentinel System

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

510(k) Number

K960109 ↗

FDA Product Code

HGM

Device Class

Class II

Regulation

21 CFR Part 884.2740

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Q-Tens

  Class II

  FDA 510(k) K912460 Active Cleared 13 Nov 1991

• Q-Sd

  Class II

  FDA 510(k) K923255 Active Cleared 5 Oct 1992

• Q-Ms Neuromuscular Stimulator

  Class II

  FDA 510(k) K912462 Active Cleared 4 Jun 1992

• Sentinel Systems

  Class II

  FDA 510(k) K833395 Active Cleared 10 Jan 1984

• Quantitative Sentinel System

  Class II

  FDA 510(k) K963608 Active Cleared 11 Mar 1997

• Quantimetrix Quan Test-Red Protein Assay System

  Class II

  FDA 510(k) K904603 Active Cleared 25 Jan 1991

See all devices from Quantitative Medicine, Inc. →

• What is the Quantitative Sentinel System used for?

  The Quantitative Sentinel System is intended for use as a clinical data management system in perinatal monitoring settings, supporting the collection, organization, and analysis of obstetric and gynecologic patient data to assist clinicians in monitoring maternal and fetal status during pregnancy and labor.

• Is the Quantitative Sentinel System sterile or non-sterile, and is it reusable or single-use?

  The system is supplied as a non-sterile, reusable software-based system, meaning it does not require sterilization before use and is designed for multiple uses in clinical environments after appropriate software and hardware maintenance, as it contains no disposable components that contact the patient directly.

• How was the Quantitative Sentinel System cleared for market release?

  The device received FDA 510(k) clearance under submission K960109 on August 1, 1996, following a traditional review process, and was determined to be substantially equivalent to a legally marketed predicate device, which allowed it to be marketed for its intended use in perinatal clinical data management.