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

K Number

K252006

Validate with FDA (Live)

Device Name

OTTO Disinfecting Cap

Manufacturer

Icu Medical, Inc.

Date Cleared

2026-03-27

(273 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

K252908

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Device Name

Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle

Manufacturer

Sandstone Medical (Suzhou), Inc.

Date Cleared

2026-03-25

(194 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

K253047

Validate with FDA (Live)

Device Name

PRESSONE

Manufacturer

Nipro Medical Corporation

Date Cleared

2026-03-24

(183 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

K251980

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Device Name

ClaveQS Bag

Manufacturer

Icu Medical, Inc.

Date Cleared

2026-03-20

(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

K253622

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Device Name

Safety Pen Needle

Manufacturer

Ningbo Medsun Medical Co., Ltd.

Date Cleared

2026-03-18

(120 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

K251967

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Device Name

HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor

Manufacturer

O&M Halyard, Inc.

Date Cleared

2026-03-18

(265 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

K253267

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Device Name

CORIS System

Manufacturer

Nanosonics Limited

Date Cleared

2026-03-05

(157 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

K251788

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Device Name

Extension tube

Manufacturer

Zhuhai DR Medical Instruments Co., Ltd.

Date Cleared

2026-03-05

(267 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

K252534

Validate with FDA (Live)

Device Name

Surgical Face Mask (Ear mount)

Manufacturer

Zhejiang Hangkang Medical Equipment Co., Ltd.

Date Cleared

2026-03-03

(203 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

K251860

Validate with FDA (Live)

Device Name

Copioumed AAMI 3 Surgical Gown

Manufacturer

Copioumed International, Inc.

Date Cleared

2026-02-26

(254 days)

Product Code

Regulation Number

Type

Panel

Age Range

All

Reference & Predicate Devices

K170762

Predicate For

N/A

Intended Use

Copioumed AAMI 3 Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect both surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate materials. The gown is single-use, disposable, and provided sterile, and is classified as AAMI Level 3.

Device Description

Copioumed AAMI 3 Surgical Gown provides protection with the materials of SMS. Copioumed AAMI 3 Surgical Gown has comfort and breathability and for a better fit on the user. The neck design of Copioumed Surgical Gown is adjustable and closes with a Velcro. Copioumed Surgical Gown is available in several sizes and lengths with two models (standard performance and high standard).

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