Cleared Traditional

K133028 - RITHM ID ELECTROPHYSIOLOGY CATHETER

K133028 is an FDA 510(k) clearance for RITHM ID ELECTROPHYSIOLOGY CATHETER, manufactured by Synaptic Medical Limited. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K133028 · Synaptic Medical Limited · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
159d
Days
Class 2
Risk

K133028 is an FDA 510(k) clearance for the RITHM ID ELECTROPHYSIOLOGY CATHETER. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Synaptic Medical Limited (Shanghai, CN). The FDA issued a Cleared decision on March 4, 2014 after a review of 159 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. 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.

FDA 510(k) Submission Details - K133028

510(k) Number K133028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2013
Decision Date March 04, 2014
Days to Decision 159 days
Submission Type Traditional
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
34d slower than avg
Panel avg: 125d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 169
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K133028.
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K122461 · Rhythmia Medical, Inc. · Apr 2013
RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
K120544 · St Jude Medical · Mar 2012
K133028 · RITHM ID ELECTROPHYSIOLOGY CATHETER
Download PDF FDA Summary Synaptic Medical Limi…