Cleared Traditional

K841885 - FASTPASS IMPLANTABLE ENDOCARDIAL PAC

K841885 is the FDA 510(k) clearance for FASTPASS IMPLANTABLE ENDOCARDIAL PAC by Pacesetter Systems. It is a Class 2 Cardiovascular device (product code DTD) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K841885 · Pacesetter Systems · Cardiovascular device
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Aug 1984
Decision
88d
Days
Class 2
Risk

K841885 is an FDA 510(k) clearance for the FASTPASS IMPLANTABLE ENDOCARDIAL PAC. 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 August 3, 1984 after a review of 88 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 K841885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1984
Decision Date August 03, 1984
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 K841885.
BIPOLAR ENDOCARDIAL LEAD 406L
K841227 · Siemens Elema AB · Nov 1984
SENTRA
K843060 · Cardiac Pacemakers, Inc. · Sep 1984
MODEL 866 PERMATHANE BIPOLAR, COAXIAL
K841739 · Pacesetter Systems · Aug 1984
IMPLANTABLE ELECTRODE BIPOLAR ADAPT
K840025 · Telectronics, Inc. · May 1984
IMPLANTABLE ELECTRODE UNIPOLAR ADAPT
K840026 · Telectronics, Inc. · May 1984
LEAD ADAPTERS #'S 6016,6022,6017 ETC
K831160 · Cardiac Pacemakers, Inc. · May 1983