Cleared Traditional

K830315 - DUAL CHANNEL RECORDER #78574A

K830315 is the FDA 510(k) clearance for DUAL CHANNEL RECORDER #78574A by Hewlett-Packard Co.. It is a Class 1 Cardiovascular device (product code DSF) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K830315 · Hewlett-Packard Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1983
Decision
59d
Days
Class 1
Risk

K830315 is an FDA 510(k) clearance for the DUAL CHANNEL RECORDER #78574A. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on March 31, 1983 after a review of 59 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K830315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1983
Decision Date March 31, 1983
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 50
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K830315.
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
MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3
K822978 · Siemens Corp. · Dec 1982
MINGOCARD 7 & MINGOPHONE 7
K822983 · Siemens Corp. · Nov 1982
MODEL 525 NEO-TRAK NEONATAL RECORDER
K823210 · Ge Medical Systems Information Technologies · Nov 1982