Cleared Traditional

K921207 - DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARD...

K921207 is an FDA 510(k) clearance for DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARD..., manufactured by Physiometrix, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K921207 · Physiometrix, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
215d
Days
Class 2
Risk

K921207 is an FDA 510(k) clearance for the DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Physiometrix, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 13, 1992 after a review of 215 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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 Physiometrix, Inc. devices

FDA 510(k) Submission Details - K921207

510(k) Number K921207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1992
Decision Date October 13, 1992
Days to Decision 215 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 125d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 117
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K921207.
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TRACETS SME 5000
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TRACET AG 4000
K904512 · Lectec Corp. · Jan 1991