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Record Keeping/Data Management System

by Critical Care Systems, Inc. 510(k)

Active United States

510(k) K865035

Overview

This device is a record keeping/data management system. It is designed for the storage, retrieval, and management of clinical data in healthcare settings.

It is supplied as a reusable system for use in clinical environments such as hospitals or critical care units. The device received FDA 510(k) clearance (K865035) on May 11, 1987, and is classified under product code DQK with cardiovascular advisory committee review. No claims are made regarding sterility, single-use status, MRI safety, sizes, or storage conditions, as these details are not provided in the source data.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK865035 Date11 May 1987ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DQK
Device Class
Class II
Regulation
21 CFR Part 870.1425
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the RECORD KEEPING/DATA MANAGEMENT SYSTEM used for?

    It is designed for the storage, retrieval, and management of clinical data in healthcare settings such as hospitals or critical care units, enabling organized handling of patient information.

  • Is the RECORD KEEPING/DATA MANAGEMENT SYSTEM reusable or single-use?

    It is supplied as a reusable system, meaning it is intended for repeated use in clinical environments rather than disposal after a single application.

  • Does the RECORD KEEPING/DATA MANAGEMENT SYSTEM require sterilization?

    No claims are made regarding sterility in the source data, so it is not indicated as a sterile device and should not be assumed to require or have undergone sterilization processes.

  • What regulatory pathway was used for the RECORD KEEPING/DATA MANAGEMENT SYSTEM?

    The device received FDA 510(k) clearance under submission K865035 on May 11, 1987, indicating it was found substantially equivalent to a legally marketed predicate device.

  • Are there specified sizes, models, or storage conditions for the RECORD KEEPING/DATA MANAGEMENT SYSTEM?

    No details regarding sizes, models, or storage conditions are provided in the source data, so such specifications cannot be confirmed or inferred from the available information.