Cleared Traditional

INTERMEDICS CYBERLITH BIPOLAR CARDIAC (K811221) - FDA 510(k) Clearance

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

K811221 · Intermedics, Inc. · Cardiovascular device
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May 1981
Decision
23d
Days
Class 3
Risk

K811221 is an FDA 510(k) clearance for the INTERMEDICS CYBERLITH BIPOLAR CARDIAC. 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 May 27, 1981 after a review of 23 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 K811221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1981
Decision Date May 27, 1981
Days to Decision 23 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
102d faster than avg
Panel avg: 125d · This submission: 23d
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 K811221.
UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.
K811350 · Medtronic Vascular · Jul 1981
MODELS 5976/5977 PACEMAKER PULSE GENER
K810677 · Medtronic, Inc. · May 1981
MEDTRONIC PULSE GENERATOR
K811123 · Medtronic Vascular · May 1981
MODELS 8420 THRU 8423 PACEMAKER GENER
K810734 · Medtronic Vascular · May 1981
THINLITH III UNIPOLAR CARDIAC PULSE GEN.
K810752 · Intermedics, Inc. · May 1981
MODEL 230-05 CYBERLITH I BIPOL. PULSE G.
K810800 · Intermedics, Inc. · May 1981