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

K Number

K243598

Device Name

Welch Allyn Connex® 360 (Multiple)

Manufacturer

Welch Allyn, Inc.

Date Cleared

2025-07-13

(234 days)

Product Code

N/A

Regulation Number

N/A

Intended Use

Device Description

K Number

K243199

Device Name

NightWatch+ US

Manufacturer

LivAssured BV

Date Cleared

2025-07-12

(284 days)

Product Code

POS

Regulation Number

882.1580

Intended Use

Device Description

K Number

K241179

Device Name

Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)

Manufacturer

VivaQuant, Inc.

Date Cleared

2025-07-11

(438 days)

Product Code

MLO

Regulation Number

870.2800

Intended Use

Device Description

K Number

K243227

Device Name

B-Scan

Manufacturer

ACCUTOME, INC. Doing Business As Keeler USA

Date Cleared

2025-07-11

(276 days)

Product Code

IYO

Regulation Number

892.1560

Intended Use

Device Description

K Number

K243274

Device Name

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

Manufacturer

Centers for Disease Control and Prevention

Date Cleared

2025-07-11

(268 days)

Product Code

OZE

Regulation Number

866.3980

Intended Use

Device Description

K Number

K243296

Device Name

Disposable Biopsy Needle

Manufacturer

Carbon (Shenzhen) Medical Device Co., Ltd.

Date Cleared

2025-07-11

(266 days)

Product Code

KNW

Regulation Number

876.1075

Intended Use

Device Description

K Number

K243655

Device Name

TurbAlign

Manufacturer

Spirair, Inc

Date Cleared

2025-07-11

(227 days)

Product Code

LYA

Regulation Number

874.4780

Intended Use

Device Description

K Number

K250034

Device Name

Natural rubber latex male condom

Manufacturer

Shaoguan Regenex Pharmaceuticals Co., Ltd.

Date Cleared

2025-07-11

(185 days)

Product Code

HIS

Regulation Number

884.5300

Intended Use

Device Description

K Number

K250156

Device Name

Choice 2 DC

Manufacturer

Bisco, Inc

Date Cleared

2025-07-11

(171 days)

Product Code

EMA

Regulation Number

872.3275

Intended Use

Device Description

K Number

K250266

Device Name

Ceragem Automatic Thermal Massager (CGM MB-2401)

Manufacturer

CERAGEM Co, Ltd.

Date Cleared

2025-07-11

(162 days)

Product Code

JFB, IRO, IRP, ISA

Regulation Number

890.5880

Intended Use

Device Description

K Number

K250671

Device Name

FreeStyle Comfort (AS200 / FreeStyle Comfort)

Manufacturer

CAIRE Inc.

Date Cleared

2025-07-11

(128 days)

Product Code

CAW

Regulation Number

868.5440

Intended Use

Device Description

K Number

K250761

Device Name

KALA Therapy Wand (Model: KALA-03)

Manufacturer

SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD

Date Cleared

2025-07-11

(120 days)

Product Code

OHS, ISA, OLP

Regulation Number

878.4810

Intended Use

Device Description

K Number

K250762

Device Name

ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

Manufacturer

Olympus Medical Systems Corporation

Date Cleared

2025-07-11

(120 days)

Product Code

ITX

Regulation Number

892.1570

Intended Use

Device Description

K Number

K250772

Device Name

Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

Manufacturer

Surgical Instrument Service and Savings Inc.

Date Cleared

2025-07-11

(120 days)

Product Code

NLH

Regulation Number

870.1220

Intended Use

Device Description

K Number

K250820

Device Name

Disposable Trocars

Manufacturer

Sinolinks Medical Innovation, Inc.

Date Cleared

2025-07-11

(115 days)

Product Code

GCJ

Regulation Number

876.1500

Intended Use

Device Description

K Number

K250942

Device Name

Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)

Manufacturer

Shenzhen Ulike Smart Electronics Co., Ltd.

Date Cleared

2025-07-11

(105 days)

Product Code

OHT

Regulation Number

878.4810

Intended Use

Device Description

K Number

K251134

Device Name

RipCord

Manufacturer

TriMed, Inc.

Date Cleared

2025-07-11

(91 days)

Product Code

HTN

Regulation Number

888.3030

Intended Use

Device Description

K Number

K251149

Device Name

AviClear Laser System

Manufacturer

Cutera, Inc.

Date Cleared

2025-07-11

(88 days)

Product Code

GEX

Regulation Number

878.4810

Intended Use

Device Description

K Number

K251155

Device Name

BD Cathena Safety IV Catheter

Manufacturer

Becton Dickinson Infusion Therapy Systems Inc.

Date Cleared

2025-07-11

(88 days)

Product Code

FOZ

Regulation Number

880.5200

Intended Use

Device Description

K Number

K251352

Device Name

Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)

Manufacturer

Codonics.Incorporated

Date Cleared

2025-07-11

(72 days)

Product Code

BSZ

Regulation Number

868.5160

Intended Use

Device Description

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