Quinton Status 1000
by Quinton, Inc. 510(k)
Active
510(k) K782072
Overview
The Quinton Status 1000 is a Class II cardiac pacemaker designed for temporary or permanent pacing of the heart. It delivers electrical impulses to regulate heart rhythm in patients with bradycardia or conduction disorders, ensuring consistent cardiac output. As a pacemaker, it is intended for use in clinical settings where cardiac rhythm management is required, such as hospitals and cardiac care units. Its functionality aligns with the Device Type DQK (Cardiac Pacemaker, Temporary or Permanent) as classified by regulatory authorities.
The device is supplied as a reusable medical instrument, intended for use in controlled clinical environments such as cardiac catheterization labs or intensive care units. It operates under sterile conditions when implanted or connected to the patient, adhering to standard infection control protocols. The Quinton Status 1000 holds FDA 510(k) clearance (K782072) under the Cardiovascular (CV) Advisory Committee, with a decision dated February 23, 1979, classified as Substantially Equivalent (SESE). No additional regulatory markings or sterility guarantees are specified beyond its intended clinical use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK782072 | Date23 Feb 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
Other devices from Quinton, Inc.
Questions
What is the Quinton Status 1000 used for?
The Quinton Status 1000 is designed to regulate heart rhythm in patients with bradycardia (slow heart rate) or conduction disorders by delivering electrical impulses to the heart. It ensures consistent cardiac output and is intended for use in clinical settings like hospitals and cardiac care units where cardiac rhythm management is required.
Is the Quinton Status 1000 a single-use or reusable device?
The Quinton Status 1000 is supplied as a reusable medical instrument. It is intended for use in controlled clinical environments such as cardiac catheterization labs or intensive care units, where it can be utilized repeatedly under proper maintenance and infection control protocols.
What regulatory clearance does the Quinton Status 1000 hold?
The Quinton Status 1000 holds FDA 510(k) clearance (K782072) under the Cardiovascular (CV) Advisory Committee. It was classified as Substantially Equivalent (SESE) with a decision date of February 23, 1979, indicating it meets regulatory standards for cardiac pacemakers.
How is the Quinton Status 1000 supplied and used in clinical settings?
The device is supplied as a reusable instrument and is intended for use in sterile conditions when implanted or connected to the patient. It adheres to standard infection control protocols to ensure patient safety in clinical environments like cardiac catheterization labs or intensive care units.
What type of device classification does the Quinton Status 1000 fall under?
The Quinton Status 1000 is classified under the Device Type DQK, which corresponds to Cardiac Pacemakers (Temporary or Permanent) as defined by regulatory authorities. This classification aligns with its intended use for managing heart rhythm disorders.