Cleared Traditional

K844793 - SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR

K844793 is an FDA 510(k) clearance for SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR, manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K844793 · Intermedics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
60d
Days
Class 3
Risk

K844793 is an FDA 510(k) clearance for the SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on February 8, 1985 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K844793

510(k) Number K844793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1984
Decision Date February 08, 1985
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DXY Implantable Pacemaker Pulse-generator

All 354
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K844793.
CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER
K850384 · Cardiac Control Systems, Inc. · Mar 1985
EKG TRANSMITTER MODEL 5134
K842051 · Instromedix, Inc. · Mar 1985
COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM
K850656 · Cook Pacemaker Corp. · Mar 1985
MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR
K844957 · Medtronic Vascular · Feb 1985
MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE
K844958 · Medtronic Vascular · Feb 1985
MULTILITH PULSE GENERATORS, 1141 & 2141
K842193 · Ela Medical, Inc. · Jan 1985