RadAR Vascular Compression Device

FDA UDI

Class II (US FDA UDI)

by Semler Technologies, Inc.

Identity

Trade Name: RadAR Vascular Compression Device FDA UDI
Generic Name: Radial artery compression device FDA UDI
Device Name: The RadAR Vascular Compression Device Model 4150 provides economical, safe hemostasis for your post-catheterization radial access patients. The user can quickly make compression adjustements to permit patent blood flow through the artery and gradually release pressure during hemostasis, without unfastening the device. This enables patent hemostatsis which has been shown to reduce the incidence of chronic radial artery occlusion. The Model 4150 is blue in color. FDA UDI
Model / Reference: 4150 FDA UDI
Description: The RadAR Vascular Compression Device Model 4150 provides economical, safe hemostasis for your post-catheterization radial access patients. The user can quickly make compression adjustements to permit patent blood flow through the artery and gradually release pressure during hemostasis, without unfastening the device. This enables patent hemostatsis which has been shown to reduce the incidence of chronic radial artery occlusion. The Model 4150 is blue in color. FDA UDI

Identifiers

Catalog Number: 140-0150-00 FDA UDI
Primary DI / UDI-DI: 10815614020071 FDA UDI
510(k) Number: K142122 FDA UDI
FDA Product Code: DXC FDA UDI
GMDN Term: Radial artery compression device FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Radial artery compression device

RadAR Vascular Compression Device by Semler Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Radial artery compression device.

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PreludeSYNC™ — Merit Medical Systems, Inc. · Class II
TRAcelet™ — MEDTRONIC, INC. · Class II
PreludeSYNC DISTAL™ — Merit Medical Systems, Inc. · Class II
PreludeSYNC EVO™ — Merit Medical Systems, Inc. · Class II

Cleared under the same submission

K142122 also covers:

RadAR Vascular Compression Device — Semler Technologies, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Semler Technologies, Inc.

Sources (1)

FDA UDI 7517b689-c7cd-456a-acc5-3c5fc8806fab 35 fields · synced May 30, 2026