Cleared Traditional

SUPRIMA II MODEL 254-26 (K852431) - FDA 510(k) Clearance

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

K852431 · Intermedics, Inc. · Cardiovascular device
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Jul 1985
Decision
39d
Days
Class 3
Risk

K852431 is an FDA 510(k) clearance for the SUPRIMA II MODEL 254-26. 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 July 19, 1985 after a review of 39 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 K852431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1985
Decision Date July 19, 1985
Days to Decision 39 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
86d faster than avg
Panel avg: 125d · This submission: 39d
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 K852431.
BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS
K854143 · Telectronics, Inc. · Nov 1985
IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW
K853206 · Telectronics, Inc. · Sep 1985
#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ
K853034 · Intermedics, Inc. · Jul 1985
SUPRIMA II MODEL 253-23
K852430 · Intermedics, Inc. · Jul 1985
SUPRIMA II MODEL 254-28
K852432 · Intermedics, Inc. · Jul 1985
MULTICOR S, MODELS 330A/331A
K851420 · Cordis Corp. · Jun 1985