Cleared Traditional

MODEL 366-19 ADAPTAID ADAPTER SLEEVE (K860985) - FDA 510(k) Clearance

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

K860985 · Intermedics, Inc. · Cardiovascular device

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Mar 1986

Decision

14d

Days

Class 3

Risk

K860985 is an FDA 510(k) clearance for the MODEL 366-19 ADAPTAID ADAPTER SLEEVE. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on March 31, 1986 after a review of 14 days - a notably fast clearance cycle.

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 Intermedics, Inc. devices

Submission Details

510(k) Number	K860985 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 17, 1986
Decision Date	March 31, 1986
Days to Decision	14 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

111d faster than avg

Panel avg: 125d · This submission: 14d

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 221

Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K860985.

MODEL 492-02 ENDOCARDIAL PACING LEAD

K860548 · Intermedics, Inc. · Jun 1986

MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER

K861176 · Intermedics, Inc. · Apr 1986

MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER

K861110 · Intermedics, Inc. · Apr 1986

MODEL 366-09 ADAPTAID ADAPTER SLEEVE

K860986 · Intermedics, Inc. · Mar 1986

MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD

K854917 · Intermedics, Inc. · Mar 1986

MODEL 431-01 BIOPORE IMPLANTABLE PACING LEAD

K854918 · Intermedics, Inc. · Mar 1986

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K860985

Intermedics, Inc.

Freeport, TX · US

KEN BISHOP

Regulatory profile

211 submissions 201 cleared

95% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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