Cleared Traditional

K883037 - UNILITH 3 MODELS 7580/7583/7680/7683

K883037 is the FDA 510(k) clearance for UNILITH 3 MODELS 7580/7583/7680/7683 by Ela Medical, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K883037 · Ela Medical, Inc. · Cardiovascular device
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Jan 1989
Decision
190d
Days
Class 3
Risk

K883037 is an FDA 510(k) clearance for the UNILITH 3 MODELS 7580/7583/7680/7683. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on January 25, 1989 after a review of 190 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 Ela Medical, Inc. devices

Submission Details

510(k) Number K883037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1988
Decision Date January 25, 1989
Days to Decision 190 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
65d slower than avg
Panel avg: 125d · This submission: 190d
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 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K883037.
ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
K890785 · Cardiac Pacemakers, Inc. · Mar 1989
AFP MODEL 262T PULSE GENERATOR
K884733 · Pacesetter Systems · Feb 1989
OPTIMA MPT AND SPT PACEMAKERS
K884411 · Telectronics, 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