Cleared Traditional

K883750 - VENTRALITH I

K883750 is an FDA 510(k) clearance for VENTRALITH I, manufactured by Bio Pace Technology, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K883750 · Bio Pace Technology, Inc. · Cardiovascular device
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Jan 1989
Decision
134d
Days
Class 3
Risk

K883750 is an FDA 510(k) clearance for the VENTRALITH I. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Bio Pace Technology, Inc. (Butler, US). The FDA issued a Cleared decision on January 13, 1989 after a review of 134 days - within the typical 510(k) review window.

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 Bio Pace Technology, Inc. devices

FDA 510(k) Submission Details - K883750

510(k) Number K883750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1988
Decision Date January 13, 1989
Days to Decision 134 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 125d · This submission: 134d
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 K883750.
AFP MODEL 262T PULSE GENERATOR
K884733 · Pacesetter Systems · Feb 1989
OPTIMA MPT AND SPT PACEMAKERS
K884411 · Telectronics, Inc. · Jan 1989
UNILITH 3 MODELS 7580/7583/7680/7683
K883037 · Ela Medical, Inc. · Jan 1989
MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS
K883755 · Medtronic Vascular · Nov 1988
MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331
K884215 · Medtronic Vascular · Nov 1988
OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024
K882391 · Ela Medical, Inc. · Nov 1988