Cleared Traditional

K810121 - UNIFOCAL 3

K810121 is an FDA 510(k) clearance for UNIFOCAL 3, manufactured by American Pacemaker Corp.. The device is a Class 3 Radiology device with product code DXY cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K810121 · American Pacemaker Corp. · Radiology device
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Feb 1981
Decision
35d
Days
Class 3
Risk

K810121 is an FDA 510(k) clearance for the UNIFOCAL 3. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by American Pacemaker Corp. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1981 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.3610 - the FDA radiology and imaging software 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Pacemaker Corp. devices

FDA 510(k) Submission Details - K810121

510(k) Number K810121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1981
Decision Date February 23, 1981
Days to Decision 35 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 107d · This submission: 35d
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 394
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K810121.
CYBERLITH I PULSE GENERATOR MODEL 253-04
K810385 · Intermedics, Inc. · Apr 1981
THINLITH II PULSE GNEERATOR MODEL 227-05
K810386 · Intermedics, Inc. · Mar 1981
STERILE PACKAGING
K810410 · Telectronics, Inc. · Mar 1981
MULTI-PROGRAMMABLE PACEMAKER & PROGRMR.
K801584 · Medtronic Vascular · Feb 1981
SIEMENS-ELEMA PULSE GENERATOR 678
K802864 · Siemens Elema AB · Feb 1981
SIEMENS-ELEMA MYOCARDIAL LEAD
K810036 · Siemens Elema AB · Jan 1981