Cleared Traditional

K912562 - ABCOM 2000

K912562 is an FDA 510(k) clearance for ABCOM 2000, manufactured by Applied Biometrics, Inc.. The device is a Class 2 Radiology device with product code DPW cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K912562 · Applied Biometrics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
212d
Days
Class 2
Risk

K912562 is an FDA 510(k) clearance for the ABCOM 2000. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Applied Biometrics, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on January 9, 1992 after a review of 212 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.2100 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Applied Biometrics, Inc. devices

FDA 510(k) Submission Details - K912562

510(k) Number K912562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1991
Decision Date January 09, 1992
Days to Decision 212 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 107d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPW Device Classification - Class 2, Special Controls

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - DPW Flowmeter, Blood, Cardiovascular

All 81
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K912562.
SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR
K942613 · Koven Technology, Inc. · Dec 1994
MS DISPOSABLE RIGID DOPPLER PROBE
K930227 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1993
CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R)
K925524 · Cardio Metrics, Inc. · Aug 1993
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG
K913827 · Hewlett-Packard Co. · Nov 1991
INTERSPEC APOGEE, MODIFICATION
K910049 · Interspec, Inc. · Apr 1991
FLOWIRE AND FLOMAP
K905411 · Cardio Metrics, Inc. · Mar 1991