Cleared Traditional

K882327 - PACER SENSING ANALYZER (PSA 100)

K882327 is an FDA 510(k) clearance for PACER SENSING ANALYZER (PSA 100), manufactured by Oscor Medical Corp.. The device is a Class 2 Cardiovascular device with product code DTC cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K882327 · Oscor Medical Corp. · Cardiovascular device
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Oct 1988
Decision
122d
Days
Class 2
Risk

K882327 is an FDA 510(k) clearance for the PACER SENSING ANALYZER (PSA 100). Classified as Analyzer, Pacemaker Generator Function (product code DTC), Class II - Special Controls.

Submitted by Oscor Medical Corp. (Palm Harbor, US). The FDA issued a Cleared decision on October 6, 1988 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3630 - 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: Standard predicate-based submission. Standard predicate reliance. 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 Oscor Medical Corp. devices

FDA 510(k) Submission Details - K882327

510(k) Number K882327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1988
Decision Date October 06, 1988
Days to Decision 122 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
3d faster than avg
Panel avg: 125d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTC Device Classification - Class 2, Special Controls

Product Code DTC Analyzer, Pacemaker Generator Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3630
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 - DTC Analyzer, Pacemaker Generator Function

All 25
Devices cleared under the same product code (DTC) and FDA review panel - the closest regulatory comparables to K882327.
PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE
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MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER
K884331 · Medtronic Vascular · Jan 1989
SEAMED MODEL 3000
K860462 · Seamed Corp. · Aug 1986
SEA MED DDD PACING SYSTEM ANALYZER
K851900 · Seamed Corp. · Jul 1985
MEDTRONIC 5311 PACING SYSTEM ANALYZER
K850077 · Medtronic Vascular · Jul 1985