Cleared Traditional

K123035 - SEAL ONE

K123035 is an FDA 510(k) clearance for SEAL ONE, manufactured by Perouse Medical. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K123035 · Perouse Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
61d
Days
Class 2
Risk

K123035 is an FDA 510(k) clearance for the SEAL ONE. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Perouse Medical (Irigny, FR). The FDA issued a Cleared decision on November 28, 2012 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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.

FDA 510(k) Submission Details - K123035

510(k) Number K123035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2012
Decision Date November 28, 2012
Days to Decision 61 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
64d faster than avg
Panel avg: 125d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 193
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K123035.
CATALYST II AND III
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AIR-BAND RADIAL COMPRESSION DEVICE
K122405 · Datascope Corp., Cardiac Assist Division · Nov 2012
K2 MEDICAL VASCULAR CLAMPS
K120492 · K2 Medical GmbH & Co. KG · Apr 2012
IM BAND
K113600 · Synexmed(Shenzhen)Company Limited · Feb 2012
K123035 · SEAL ONE
Download PDF FDA Summary Perouse Medical