Cleared Traditional

CYBERLITH I PULSE GENERATOR MODEL 253-04 (K810385) - FDA 510(k) Clearance

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

K810385 · Intermedics, Inc. · Cardiovascular device
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Apr 1981
Decision
47d
Days
Class 3
Risk

K810385 is an FDA 510(k) clearance for the CYBERLITH I PULSE GENERATOR MODEL 253-04. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 1, 1981 after a review of 47 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 K810385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1981
Decision Date April 01, 1981
Days to Decision 47 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
78d faster than avg
Panel avg: 125d · This submission: 47d
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 K810385.
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE
K810603 · Telectronics, Inc. · Apr 1981
INSULATIVE COATING FOR CARD. PULSE GEN
K810901 · Intermedics, Inc. · Apr 1981
INTERMEDICS CYBERLITH I BIOPOLAR CARDI
K810383 · 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