Cleared Traditional

K874394 - QUANTUM MODELS 253-19V & 254-20V PULSE ...

K874394 is an FDA 510(k) clearance for QUANTUM MODELS 253-19V & 254-20V PULSE ..., 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 26-day FDA review.

K874394 · Intermedics, Inc. · Cardiovascular device
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Nov 1987
Decision
26d
Days
Class 3
Risk

K874394 is an FDA 510(k) clearance for the QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.. 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 November 23, 1987 after a review of 26 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 - K874394

510(k) Number K874394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date November 23, 1987
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
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 K874394.
MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS
K880326 · Cardiac Control Systems, Inc. · Apr 1988
MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER
K880422 · Cardiac Control Systems, Inc. · Mar 1988
CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK.
K874158 · Cardiac Control Systems, Inc. · Dec 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K872766 · Telectronics, Inc. · Nov 1987
PROLOG MP PULSE GENERATORS 658K AND 658T
K872779 · Pacesetter Systems · Nov 1987
MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS
K873528 · Intermedics, Inc. · Oct 1987