Cleared Traditional

K821549 - PACEMAKER 445 ADAPTER

K821549 is the FDA 510(k) clearance for PACEMAKER 445 ADAPTER by Pacesetter Systems. It is a Class 2 Cardiovascular device (product code DTD) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K821549 · Pacesetter Systems · Cardiovascular device

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Jun 1982

Decision

Days

Class 2

Risk

K821549 is an FDA 510(k) clearance for the PACEMAKER 445 ADAPTER. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Pacesetter Systems (Mchenry, US). The FDA issued a Cleared decision on June 2, 1982 after a review of 8 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 Pacesetter Systems devices

Submission Details

510(k) Number	K821549 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 25, 1982
Decision Date	June 02, 1982
Days to Decision	8 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

117d faster than avg

Panel avg: 125d · This submission: 8d

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 84

Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K821549.

MODEL 366-07 ADAPT AID LEAD ADAPTER

K822704 · Intermedics, Inc. · Nov 1982

PACEMAKER UNIPOLAR ADAPTER

K821547 · Pacesetter Systems · Jun 1982

PACEMAKER CONNECTOR PLUG

K821548 · Pacesetter Systems · Jun 1982

MODEL 5866-26 LEAD ADAPTER KIT

K820935 · Medtronic Vascular · Apr 1982

VITATRON INSERT

K813151 · Pacesetter Systems · Dec 1981

ELECTRODE TERMINAL CAP

K813152 · Pacesetter Systems · Dec 1981

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 K821549

Pacesetter Systems

Mchenry, IL · US

Regulatory profile

96 submissions 96 cleared

100% 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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