Cleared Traditional

K810561 - DOPSCAN MODEL 1050

K810561 is an FDA 510(k) clearance for DOPSCAN MODEL 1050, manufactured by Carolina Medical Electronics. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K810561 · Carolina Medical Electronics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1981
Decision
38d
Days
Class 2
Risk

K810561 is an FDA 510(k) clearance for the DOPSCAN MODEL 1050. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Carolina Medical Electronics (Walker, US). The FDA issued a Cleared decision on April 10, 1981 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - the FDA cardiovascular device 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Carolina Medical Electronics devices

FDA 510(k) Submission Details - K810561

510(k) Number K810561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1981
Decision Date April 10, 1981
Days to Decision 38 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 125d · This submission: 38d
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 Cardiovascular 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 K810561.
PERIFLUX PF-2
K844631 · Medex, Inc. · Feb 1985
XOMED PATENCY MONITOR
K821373 · Xomed, Inc. · Jul 1982
NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100
K820742 · Nihon Kohden America, Inc. · Apr 1982
EMIT TOBRAMYCIN CONTROL
K800151 · Syva Co. · Feb 1980
BLOOD FLOWMETER SYSTEM
K780302 · Medtronic Vascular · Apr 1978