Cleared Special

K991025 - LUMA-CATH FIXED CURVE EP CATHETERS

K991025 is an FDA 510(k) clearance for LUMA-CATH FIXED CURVE EP CATHETERS, manufactured by Irvine Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Special 510(k) pathway after a 200-day FDA review.

K991025 · Irvine Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
200d
Days
Class 2
Risk

K991025 is an FDA 510(k) clearance for the LUMA-CATH FIXED CURVE EP CATHETERS. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Irvine Biomedical, Inc. (Irvine, US). The FDA issued a Cleared decision on October 15, 1999 after a review of 200 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K991025

510(k) Number K991025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1999
Decision Date October 15, 1999
Days to Decision 200 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 125d · This submission: 200d
Pathway characteristics
Modification to existing cleared device.

DRF Device Classification - Class 2, Special Controls

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 180
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K991025.
LUMA-CATH STEERABLE EP CATHETERS
K991878 · Irvine Biomedical, Inc. · Dec 1999
CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
K992965 · Cordis Webster, Inc. · Nov 1999
ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE
K992373 · C.R. Bard, Inc. · Nov 1999
CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078
K991531 · Cordis Webster, Inc. · Oct 1999
MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER
K991001 · Ep Medsystems · Jul 1999
ORTHOGONAL EP CATHETERS
K990958 · Irvine Biomedical, Inc. · Jun 1999
K991025 · LUMA-CATH FIXED CURVE EP CATHETERS
Download PDF FDA Summary Irvine Biomedical, In…