Cleared Special

K002767 - COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE

K002767 is an FDA 510(k) clearance for COMPRESSAR FEMORAL ACCESS COMPRESSION D..., manufactured by Semler Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Special 510(k) pathway after a 21-day FDA review.

K002767 · Semler Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
21d
Days
Class 2
Risk

K002767 is an FDA 510(k) clearance for the COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Semler Technologies, Inc. (Vancouver, US). The FDA issued a Cleared decision on September 27, 2000 after a review of 21 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. 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. Low regulatory complexity profile. 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 - K002767

510(k) Number K002767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2000
Decision Date September 27, 2000
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 204
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K002767.
MALLEABLE SHAFT CLAMP
K011078 · Allegiance Healthcare Corp. · Jul 2001
GUIDANT AXIUS CORONARY SHUNT
K010117 · Cardiothoracic Systems, Inc. · Apr 2001
FLEXIBLE OCCLUSION SYSTEM
K002915 · Applied Medical · Jan 2001
ENGAGE JAW INSERTS
K992980 · Novare Surgical Systems, Inc. · Jun 2000
SOFTLINE SPRING CLIP
K000098 · Novare Surgical Systems, Inc. · Apr 2000
PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
K992174 · Pilling Weck Surgical · Mar 2000
K002767 · COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE
Download PDF FDA Summary Semler Technologies, …