Cleared Traditional

K760272 - CIRCUIT

K760272 is an FDA 510(k) clearance for CIRCUIT, manufactured by Burdick Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K760272 · Burdick Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1976
Decision
113d
Days
Class 2
Risk

K760272 is an FDA 510(k) clearance for the CIRCUIT, PRINTED, SERVO-MECHANISM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Burdick Corp. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1976 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Burdick Corp. devices

FDA 510(k) Submission Details - K760272

510(k) Number K760272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1976
Decision Date November 12, 1976
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPS Electrocardiograph

All 277
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K760272.
ELECTROCARDIOGRAPH MODEL 344
K770037 · Birtcher Corp. · Jan 1977
ELECTROCARDIOGRAPH, EK-7 (3-CHANNELS)
K760271 · Burdick Corp. · Nov 1976
ELECTROCARDIOGRAPH EK-6 W/OPTIONAL CIRC.
K760268 · Burdick Corp. · Nov 1976
THREE-CHANNEL STRESS TEST SYSTEM (M633)
K760854 · Quinton, Inc. · Nov 1976
MONITOR, ELECTROCARDIOSCOPE
K760266 · Burdick Corp. · Oct 1976
LIFEPAK 5 CARDIOSCOPE MODULE (NPN 5)
K760677 · Physio-Control Corp. · Oct 1976