Cleared Traditional

IMPLANTABLE PACEMAKER LEAD ADAPTER (K810245) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K810245 · Intermedics, Inc. · Cardiovascular device

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Mar 1981

Decision

34d

Days

Class 2

Risk

K810245 is an FDA 510(k) clearance for the IMPLANTABLE PACEMAKER LEAD ADAPTER. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1981 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intermedics, Inc. devices

Submission Details

510(k) Number	K810245 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 29, 1981
Decision Date	March 04, 1981
Days to Decision	34 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

91d faster than avg

Panel avg: 125d · This submission: 34d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DTD Pacemaker Lead Adaptor
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.3620

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTD Pacemaker Lead Adaptor

All 44

Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K810245.

ADAPTAID LEAD ADAPTER, #365-17

K811920 · Intermedics, Inc. · Aug 1981

ADAPTAID LEAD ADAPTER #365-25

K811938 · Intermedics, Inc. · Aug 1981

MODEL 5866-24 LEAD ADAPTOR KIT

K811349 · Medtronic Vascular · Jun 1981

ADAPTAID HELICAL COIL ADAPTER 365-14

K801039 · Intermedics, Inc. · Jul 1980

ADAPTAID ELEMA LEAD ADAPTER KIT 365-17

K801038 · Intermedics, Inc. · Jul 1980

GE LEAD ADAPTER, MODEL 345-01

K801040 · Intermedics, Inc. · Jun 1980

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 K810245

Intermedics, Inc.

Mchenry, IL · US

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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