Abcom 2000
510(k) K912562
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK912562 | Date9 Jan 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DPW
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2100
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Abcom 2000 is a blood flowmeter designed for cardiovascular applications, specifically for measuring cardiac output. As classified under FDA’s product code DPW, it functions as an extravascular Doppler-based device to monitor blood flow in clinical settings, particularly in infants and pediatric patients.
This device is supplied as a reusable medical instrument and is intended for use in hospital or clinical environments. It requires no specific sterility standards beyond standard medical device cleaning protocols. The Abcom 2000 holds an FDA 510(k) clearance (K912562) under the Traditional pathway, with a decision date of January 9, 1992, and is regulated under regulation number 870.2100. No MRI safety or single-use specifications are indicated in the available data.
Other devices from Applied Biometrics, Inc.
Questions
AI-generated answers, 20 Sep 2026
What types of patients is the Abcom 2000 primarily designed to monitor, and how does its Doppler-based technology help in this context?
The Abcom 2000 is specifically designed for measuring cardiac output in infants and pediatric patients. Its extravascular Doppler-based technology allows non-invasive blood flow measurement by detecting and analyzing the Doppler shift of ultrasound waves reflected off moving red blood cells. This is particularly useful in pediatric patients where traditional invasive methods may be impractical or risky.
Is the Abcom 2000 a single-use or reusable device, and what cleaning protocols should be followed?
The Abcom 2000 is a reusable medical instrument, intended for use in hospital or clinical environments. While it does not require specific sterility standards beyond standard medical device cleaning protocols, proper cleaning and maintenance are essential to ensure accuracy and reliability. Follow the manufacturer’s guidelines for disinfection and sterilization to prevent contamination and maintain performance.
How was the Abcom 2000’s regulatory pathway determined, and what does the FDA’s 510(k) clearance indicate about its classification?
The Abcom 2000 was cleared through the FDA’s Traditional 510(k) pathway, which means it was determined to be substantially equivalent to a legally marketed predicate device. Its classification under FDA product code DPW (Doppler, Peripheral Vascular) and regulation number 870.2100 confirms it is regulated as a Class II device, requiring special controls to ensure safety and effectiveness in measuring blood flow for cardiovascular applications.
Does the Abcom 2000 have any special considerations for storage or handling, particularly regarding its use in clinical settings?
The Abcom 2000 does not specify unique storage requirements beyond standard medical device handling. Since it is reusable, it should be stored in a clean, dry environment when not in use to prevent damage or contamination. Always follow the manufacturer’s instructions for maintenance and calibration to ensure accurate performance in clinical settings.