Cleared Traditional

CYBERLITH PROGRAMMER (K801338) - FDA 510(k) Clearance

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

K801338 · Intermedics, Inc. · Cardiovascular device
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Jan 1981
Decision
217d
Days
Class 3
Risk

K801338 is an FDA 510(k) clearance for the CYBERLITH PROGRAMMER. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Walker, US). The FDA issued a Cleared decision on January 7, 1981 after a review of 217 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 Intermedics, Inc. devices

Submission Details

510(k) Number K801338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1980
Decision Date January 07, 1981
Days to Decision 217 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
92d slower than avg
Panel avg: 125d · This submission: 217d
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 K801338.
STERILE PACKAGING
K810410 · Telectronics, Inc. · Mar 1981
MULTI-PROGRAMMABLE PACEMAKER & PROGRMR.
K801584 · Medtronic Vascular · Feb 1981
IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274
K803197 · Telectronics, Inc. · Jan 1981
IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN
K802028 · Telectronics, Inc. · Sep 1980
IMPLANTABLE PROGRAM. CARDIAC PACEMAKER
K800793 · Telectronics, Inc. · Sep 1980
MEDTRONIC MODEL 2409
K800226 · Medtronic Vascular · Sep 1980