Cleared Traditional

QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. (K874394) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

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

Submission Details

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.

Device Classification

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 181
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K874394.
MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS
K883755 · Medtronic Vascular · Nov 1988
MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331
K884215 · Medtronic Vascular · Nov 1988
OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D
K881837 · Telectronics, Inc. · Jul 1988
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K872766 · Telectronics, Inc. · Nov 1987
MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS
K873528 · Intermedics, Inc. · Oct 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K871992 · Telectronics, Inc. · Aug 1987