Cleared Traditional

K761237 - ELEC. CIR. PACE. MO. LI-2

K761237 is an FDA 510(k) clearance for ELEC. CIR. PACE. MO. LI-2, manufactured by Arco Medical Products Co.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K761237 · Arco Medical Products Co. · Cardiovascular device
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Dec 1976
Decision
8d
Days
Class 3
Risk

K761237 is an FDA 510(k) clearance for the ELEC. CIR. PACE. MO. LI-2,LI-3,LI-4,LI-5. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Arco Medical Products Co. (Mchenry, US). The FDA issued a Cleared decision on December 21, 1976 after a review of 8 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 Arco Medical Products Co. devices

FDA 510(k) Submission Details - K761237

510(k) Number K761237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1976
Decision Date December 21, 1976
Days to Decision 8 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
117d faster than avg
Panel avg: 125d · This submission: 8d
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 388
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K761237.
UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR
K770197 · Cardiac Pacemakers, Inc. · Feb 1977
BIPOLAR ASYNCHRONOUS PULSE GENERATOR
K770198 · Cardiac Pacemakers, Inc. · Feb 1977
LITHIUM IODIDE BATTERY PACEMAKER (#201)
K761143 · Pacesetter Systems · Dec 1976
PACEMAKERS, VITATRON'S
K760669 · Vitatron Medical BV · Nov 1976
PACEMAKERS, VITATRONS (SERIES 2000)
K760670 · Vitatron Medical BV · Nov 1976
PACEMAKERS, VITATRONS (SERIES 3000)
K760671 · Vitatron Medical BV · Nov 1976