FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

K Number

K252360

Validate with FDA (Live)

Device Name

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

Manufacturer

Anumana, Inc.

Date Cleared

2026-03-28

(242 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K252295

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Device Name

Ryurei

Manufacturer

Terumo Corporation

Date Cleared

2026-03-27

(247 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K260273

Validate with FDA (Live)

Device Name

Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)

Manufacturer

Shenzhen Urion Technology Co., Ltd.

Date Cleared

2026-03-26

(56 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K260626

Validate with FDA (Live)

Device Name

Multiflex Steerable Sheath 17.5F

Manufacturer

Vizaramed, Inc.

Date Cleared

2026-03-26

(28 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K254278

Validate with FDA (Live)

Device Name

Arterial Pressure Monitoring Set/Tray

Manufacturer

Spectrum Vascular

Date Cleared

2026-03-25

(85 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K260437

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Device Name

Valvuloplasty Balloon Catheter (ValvuloPro)

Manufacturer

Dongguan TT Medical, Inc.

Date Cleared

2026-03-20

(37 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K260544

Validate with FDA (Live)

Device Name

FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40

Manufacturer

FMD Co., Ltd.

Date Cleared

2026-03-20

(30 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K254208

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Device Name

FLOWRUNNER Aspiration System

Manufacturer

Expanse Medical, Inc.

Date Cleared

2026-03-20

(81 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253746

Validate with FDA (Live)

Device Name

Enroute 0.014'' Transcarotid Guidewire

Manufacturer

Lake Region Medical

Date Cleared

2026-03-19

(114 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K260188

Validate with FDA (Live)

Device Name

LimFlow Vector

Manufacturer

LimFlow, Inc.

Date Cleared

2026-03-18

(55 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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