Cleared Traditional

K801338 - CYBERLITH PROGRAMMER

K801338 is an FDA 510(k) clearance for CYBERLITH PROGRAMMER, manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 217-day FDA review.

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

FDA 510(k) Submission Details - K801338

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.

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 354
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K801338.
SIEMENS-ELEMA PULSE GENERATOR 678
K802864 · Siemens Elema AB · Feb 1981
SIEMENS-ELEMA MYOCARDIAL LEAD
K810036 · Siemens Elema AB · Jan 1981
IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274
K803197 · Telectronics, Inc. · Jan 1981
MICRO THIN-DII, #0521
K802352 · Cardiac Pacemakers, Inc. · Dec 1980
MICRO THIN-PII, #0523
K802353 · Cardiac Pacemakers, Inc. · Dec 1980
MICROTHIN-PII BIPOLAR PULSE GEN. #0623
K803034 · Cardiac Pacemakers, Inc. · Dec 1980