Cleared Traditional

K821612 - MODEL 16800 TREND RECORDER

K821612 is an FDA 510(k) clearance for MODEL 16800 TREND RECORDER, manufactured by Healthdyne, Inc.. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K821612 · Healthdyne, Inc. · Cardiovascular device
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Jul 1982
Decision
42d
Days
Class 1
Risk

K821612 is an FDA 510(k) clearance for the MODEL 16800 TREND RECORDER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Healthdyne, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1982 after a review of 42 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 Healthdyne, Inc. devices

FDA 510(k) Submission Details - K821612

510(k) Number K821612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1982
Decision Date July 14, 1982
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
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 K821612.
MINGOCARD 7 & MINGOPHONE 7
K822983 · Siemens Corp. · Nov 1982
MODEL 525 NEO-TRAK NEONATAL RECORDER
K823210 · Ge Medical Systems Information Technologies · Nov 1982
CENTURION CHART RECORDER
K822432 · Clinical Data, Inc. · Nov 1982
CARDIOVUE ACCESSORY CART
K820033 · Diasonics, Inc. · Jan 1982
VASCULAB #R12B
K812608 · Medasonics, Inc. · Oct 1981
SPACELABS' SYSTEM AUTORECORDER
K811540 · Spacelabs, Inc. · Aug 1981