Cleared Traditional

K870016 - ARTERIAL BLOOD GASSING MONITORING SYSTE...

K870016 is the FDA 510(k) clearance for ARTERIAL BLOOD GASSING MONITORING SYSTE... by Migada, Ltd.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K870016 · Migada, Ltd. · Cardiovascular device
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May 1987
Decision
146d
Days
Class 3
Risk

K870016 is an FDA 510(k) clearance for the ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG). Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Migada, Ltd. (Israel, IL). The FDA issued a Cleared decision on May 28, 1987 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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 Migada, Ltd. devices

Submission Details

510(k) Number K870016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1987
Decision Date May 28, 1987
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
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 - DTB Permanent Pacemaker Electrode

All 273
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K870016.
MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD
K870885 · Medtronic Vascular · Nov 1987
MODIFIED MODELS 1025M & 1026T PACING LEAD
K873931 · Pacesetter Systems · Oct 1987
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438
K865098 · Telectronics, Inc. · Aug 1987
IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01
K871580 · Intermedics, Inc. · May 1987
IMPLANTABLE ELECTRODE LEAD, MODEL 030-439
K864618 · Telectronics, Inc. · May 1987
ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY
K870357 · Intermedics, Inc. · May 1987