Cleared Traditional

SUPRIMA MODEL 254-22 (K852339) - FDA 510(k) Clearance

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

K852339 · Intermedics, Inc. · Cardiovascular device
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Nov 1985
Decision
158d
Days
Class 3
Risk

K852339 is an FDA 510(k) clearance for the SUPRIMA MODEL 254-22. 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 8, 1985 after a review of 158 days - an extended review 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 K852339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1985
Decision Date November 08, 1985
Days to Decision 158 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
33d slower than avg
Panel avg: 125d · This submission: 158d
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 K852339.
IMPLANTABLE PROGRAMMABLE PULSE GENERATOR
K854560 · Telectronics, Inc. · Jan 1986
CORDIS MULTICOR ST, MODEL 350A
K851968 · Cordis Corp. · Jan 1986
MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE
K854214 · Cordis Corp. · Dec 1985
SUPRIMA MODEL 254-24
K852340 · Intermedics, Inc. · Nov 1985
MEDTRONICS MODELS 8320/8322/8329
K852688 · Medtronic Vascular · Nov 1985
CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK
K852748 · Cordis Corp. · Nov 1985