Cleared Traditional

K852641 - ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER

K852641 is an FDA 510(k) clearance for ORION 40 CARDIAC STIMULATOR & PMP 200 P..., manufactured by Sorin Biomedica, Fiat, USA, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K852641 · Sorin Biomedica, Fiat, USA, Inc. · Cardiovascular device
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Jan 1986
Decision
208d
Days
Class 3
Risk

K852641 is an FDA 510(k) clearance for the ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Sorin Biomedica, Fiat, USA, Inc. (New York, US). The FDA issued a Cleared decision on January 14, 1986 after a review of 208 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 Sorin Biomedica, Fiat, USA, Inc. devices

FDA 510(k) Submission Details - K852641

510(k) Number K852641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1985
Decision Date January 14, 1986
Days to Decision 208 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
83d slower than avg
Panel avg: 125d · This submission: 208d
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 393
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K852641.
TELEMETRY WAND MODEL
K855171 · Cardiac Pacemakers, Inc. · Jan 1986
IMPLANTABLE PROGRAMMABLE PULSE GENERATOR
K854560 · Telectronics, Inc. · Jan 1986
CORDIS MULTICOR ST, MODEL 350A
K851968 · Cordis Corp. · Jan 1986
PROGRAMALITH III MODELS 238 & 239
K854195 · Pacesetter Systems · Jan 1986
BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY
K854919 · Cook Pacemaker Corp. · Dec 1985
SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM
K851365 · Sorin Biomedica, Fiat, USA, Inc. · Dec 1985