Cleared Traditional

K890142 - A10 ULTRASCOPE RECORDER

K890142 is an FDA 510(k) clearance for A10 ULTRASCOPE RECORDER, manufactured by Ems Medical, Inc.. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K890142 · Ems Medical, Inc. · Cardiovascular device
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Feb 1989
Decision
24d
Days
Class 1
Risk

K890142 is an FDA 510(k) clearance for the A10 ULTRASCOPE RECORDER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Ems Medical, Inc. (Livermore, US). The FDA issued a Cleared decision on February 6, 1989 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2810 - 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 Ems Medical, Inc. devices

FDA 510(k) Submission Details - K890142

510(k) Number K890142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1989
Decision Date February 06, 1989
Days to Decision 24 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

DSF Device Classification - Class 1, General Controls

Product Code DSF Recorder, Paper Chart
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DSF Recorder, Paper Chart

All 57
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K890142.
EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.
K893561 · Edentec Corp. · Aug 1989
CARDIOCAP(TM) DR-104 REPORTER
K885058 · Datex Division Instrumentarium Corp. · Jul 1989
FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
K884897 · Mennen Medical, Inc. · Mar 1989
EDENTEC MODEL 4700 SCANNER
K884388 · Edentec Corp. · Jan 1989
EDENTRACE MULTI-CHARTER MODEL 3700
K883315 · Edentec Corp. · Dec 1988
WS 800R THERMAL ARRAY RECORDER
K881831 · Nihon Kohden America, Inc. · Jul 1988