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

K Number

K253668

Validate with FDA (Live)

Device Name

Onera SleepMap (SLEEPMAP)

Manufacturer

Onera B.V.

Date Cleared

2026-03-08

(107 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

K253132

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Device Name

Single use stone retrieval balloons

Manufacturer

Zhejiang Chuangxiang Medical Technology Co., Ltd.

Date Cleared

2026-03-06

(162 days)

Product Code

FGE

Regulation Number

876.5010

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

K252208

Validate with FDA (Live)

Device Name

JFord Speculum Sleeve

Manufacturer

Ford Medtech, LLC

Date Cleared

2026-03-06

(234 days)

Product Code

HIB

Regulation Number

884.4530

Type

Traditional

Panel

Obstetrics/Gynecology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K260013

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Device Name

CVAC Image Processor

Manufacturer

Calyxo, Inc.

Date Cleared

2026-03-06

(60 days)

Product Code

FGB

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

K251818

Validate with FDA (Live)

Device Name

BONTREE PLUS

Manufacturer

Hudens Bio Co., Ltd.

Date Cleared

2026-03-06

(266 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

K260166

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Device Name

Bunkerhill Contrast CAC

Manufacturer

BunkerHill Health

Date Cleared

2026-03-06

(45 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

K253538

Validate with FDA (Live)

Device Name

TeKBrace Knotless Anchor

Manufacturer

Theramicro

Date Cleared

2026-03-06

(113 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

K253951

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Device Name

Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)

Manufacturer

Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Date Cleared

2026-03-06

(86 days)

Product Code

GEX

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

K260167

Validate with FDA (Live)

Device Name

Bunkerhill Contrast AVC

Manufacturer

BunkerHill Health

Date Cleared

2026-03-06

(45 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

K253772

Validate with FDA (Live)

Device Name

Velocity Alpha MR High Speed Surgical Drill System

Manufacturer

Adeor Medical AG

Date Cleared

2026-03-06

(100 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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