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

K Number

K253847

Validate with FDA (Live)

Device Name

Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)

Manufacturer

Merit Medical Ireland, Ltd.

Date Cleared

2026-01-31

(60 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

K251769

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Device Name

RevealAI-Lung

Manufacturer

Precision Medical Ventures, Inc. Dba Revealdx

Date Cleared

2026-01-30

(234 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

K254283

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Device Name

BruxZir® Shaded 16 PLUS

Manufacturer

Prismatik Dentalcraft, Inc.

Date Cleared

2026-01-30

(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

K253318

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Device Name

Clungene RSV Antigen Rapid Test

Manufacturer

Hangzhou Clongene Biotech Co., Ltd.

Date Cleared

2026-01-30

(122 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

K251407

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Device Name

Motor Handpiece and Control Unit (SDI10)

Manufacturer

Saeshin Precision Co., Ltd.

Date Cleared

2026-01-30

(269 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

K253833

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Device Name

Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)

Manufacturer

Shenzhen Jianchao Intelligent Technology Co., Ltd.

Date Cleared

2026-01-30

(60 days)

Product Code

OHS,NFO,OLP

Regulation Number

878.4810

Type

Traditional

Panel

General & Plastic Surgery

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K254305

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Device Name

BAROguard Donor Lung Preservation System

Manufacturer

Paragonix Technologies, Inc.

Date Cleared

2026-01-30

(30 days)

Product Code

KDN

Regulation Number

876.5880

Type

Special

Panel

Gastroenterology/Urology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K252457

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Device Name

Disposable Distal End Tape Hood

Manufacturer

Shanghai SeeGen Photoelectric Technology Co., Ltd.

Date Cleared

2026-01-30

(178 days)

Product Code

FDF

Regulation Number

876.1500

Type

Traditional

Panel

Gastroenterology/Urology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K250983

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Device Name

Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)

Manufacturer

Asistan Medikal

Date Cleared

2026-01-30

(305 days)

Product Code

Regulation Number

Type

Panel

Age Range

All

Reference & Predicate Devices

K182582

Predicate For

N/A

Intended Use

Used for percutaneous administration of diagnostic allergenic extracts.

Device Description

The Medblue Skin Prick Test Applicator is a sterile, single use disposable, multiple test head applicator used to administer skin test substances to the surface of the skin.

The Medblue Skin Prick Test Applicator is used for the conventional percutaneous application of substance directly onto the surface of the skin of diagnostic allergen extracts for performing skin tests for hypersensitivity reactions in individuals suspected of having allergies.

The Medblue Skin Prick Test Applicator is offered in several configurations with 1, 8, 10 or 12 test heads made of medical grade acrylic (ps158N) material arranged in a symmetrical design. Model AS 113 features a metal tip made of 301 stainless steel. All other models have acrylic tips.

Each of the test heads have a "leg". At the tip of each leg is an array of protruding test points (tines). Each leg has 1, 6, or 9 tines. The tines utilize capillary action to hold the allergenic material for percutaneous delivery when the applicator is applied to the skin. Each leg has a stopper to prevent going deeper than the epidermis thickness.

The test heads are designed to fit into the matching asymmetrical well design of a dipwell tray. The applicator loads the allergen from each well in the tray onto each test head.

When properly applied to the skin, the applicator will leave visible indentations in the patient's skin corresponding to the test heads of each applicator. The applicator is not intended to pierce the skin.

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K Number

K251981

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Device Name

Boston PICO (Boston PICO)

Manufacturer

Boston Aesthetics, Inc.

Date Cleared