Cleared Traditional

K772333 - RECORDER

K772333 is an FDA 510(k) clearance for RECORDER, manufactured by Telectronics, Inc.. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K772333 · Telectronics, Inc. · Cardiovascular device
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Feb 1978
Decision
53d
Days
Class 1
Risk

K772333 is an FDA 510(k) clearance for the RECORDER, PAPER, ECG. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1978 after a review of 53 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 Telectronics, Inc. devices

FDA 510(k) Submission Details - K772333

510(k) Number K772333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1977
Decision Date February 13, 1978
Days to Decision 53 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
72d faster than avg
Panel avg: 125d · This submission: 53d
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 50
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K772333.
ECG PAPER, 3 CHANNEL
K780597 · Abco Dealers, Inc. · Jun 1978
DRY SILVER PROCESSOR MODEL 1226
K780640 · Honeywell, Inc. · Apr 1978
MINYSTAG MN-1
K780338 · Lkb Instruments, Inc. · Mar 1978
PHYSIOLOGICAL RECORDER MODEL 721A
K772052 · Datascope Corp. · Nov 1977
PHYSIOLOGICAL RECORDER MODEL 740
K772054 · Datascope Corp. · Nov 1977
SINGLE & DUAL CHANNEL RECORDER
K772048 · Hewlett-Packard Co. · Nov 1977