Cleared Traditional

K832998 - 2-CHANNEL RECORDER

K832998 is an FDA 510(k) clearance for 2-CHANNEL RECORDER, manufactured by Litton Medical Electronics. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K832998 · Litton Medical Electronics · Cardiovascular device
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Jun 1984
Decision
288d
Days
Class 1
Risk

K832998 is an FDA 510(k) clearance for the 2-CHANNEL RECORDER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Litton Medical Electronics (Walker, US). The FDA issued a Cleared decision on June 1, 1984 after a review of 288 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Litton Medical Electronics devices

FDA 510(k) Submission Details - K832998

510(k) Number K832998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1983
Decision Date June 01, 1984
Days to Decision 288 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 125d · This submission: 288d
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 56
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K832998.
NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER
K850487 · Novametrix Medical Systems, Inc. · Mar 1985
SIREDOC, PAPER CHART RECORDER
K850146 · Siemens Medical Solutions USA, Inc. · Feb 1985
THERMAL GRAYSCALE RF-100
K843836 · Fukuda Denshi USA, Inc. · Oct 1984
I-CHANNEL RECORDER
K833000 · Litton Medical Electronics · Jun 1984
MONITORING SYSTEM AS100-AS115 RECORD
K832754 · Air-Shields, Inc. · Dec 1983
MEDICAL ELECTRONICS-PRINTER CLOCK
K832012 · Litton Medical Electronics · Oct 1983