Parker Quality & Compliance

PQC Reg Watch

Sponsor this week — one slot, $75, newsletter line and this bar

510(k) clearances

Decision dates from openFDA device 510(k) records. Newest first.

95 records

Oct 27, 2026

K260909

Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1); Sonoclot Coagulation & Platelet Function Analzyer System with Sonoclot Viewer (SCP2); Sonoclot Coagulation Analyzer System with Sonoclot Viewer (SC1)

Sienco, Inc.

JPA
Class II

Oct 27, 2026

K260586

Nimbl™ Pneumatic Compression System

Tactile Medical

JOW
Class II

Oct 27, 2026

K260520

Skin Clinic Nitro Clear for Warts and Skin Tags

Cryoconcepts LP

GEH
Class II

Oct 27, 2026

K254226

PulseAPI SmartWatch

PulseAI, Ltd.

DQK
Class II

Oct 26, 2026

K262984

Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02, Bway-FM03, Bway-FM05, Bway-FM06, Bway-FN01, Bway-E01, Bway-E02)

Shenzhen Bway Tech Co., Ltd.

OHS
Class II

Oct 26, 2026

K262864

FLOWRUNNER Aspiration System

Expanse Medical, Inc.

QEZ
Class II

Oct 26, 2026

K262720

SP Electrocautery Device (SP18 Max);SP Electrocautery Device (SP20 Max)

Single Pass, Inc.

GEI
Class II

Oct 26, 2026

K262627

Fractional CO2 Laser Therapy System (Z121)

Sanhe PERFECTLASER Technology Co., Ltd.

GEX
Class II

Oct 26, 2026

K262567

GPS Ankle

Blue Ortho

OLO
Class II

Oct 26, 2026

K262280

Mouth guard

Dongguan Yiyao Science & Technology Development Co., Ltd.

OBR
Unclassified

Oct 26, 2026

K262276

Cyperus

Contrario Medical, Inc.

MQK
Class II

Oct 26, 2026

K261997

NeuroAlign

Medivis, Inc.

HAW
Class II

Oct 26, 2026

K261763

MIM – KineticID

Mim Software, Inc.

LLZ
Class II

Oct 26, 2026

K261625

FAQ™ (FAQ 401);FAQ™ (FAQ 402)

Foreo, Inc.

NFO
Class II

Oct 26, 2026

K261156

Power Wheelchair (DC07, DC07M, DC08M, DC09F, DC10M)

Anhui JBH Medical Apparatus Co., Ltd.

ITI
Class II

Oct 26, 2026

K261155

Power Wheelchair (DC07A, DC07S, DC08A, DC08S, DC09, DC09A, DC09S, DC09M, DC10A, DC10S)

Anhui JBH Medical Apparatus Co., Ltd.

ITI
Class II

Oct 26, 2026

K261135

Trochlear Salvage Plating System

Skeletal Dynamics, Inc.

HRS
Class II

Oct 26, 2026

K260671

RP Check (RP01)

MD Diagnostics, Ltd.

CAP
Class II

Oct 26, 2026

K260350

Cysto-Urethroscopes and accessories

Hangzhou Hawk Optical Electronic Instruments Co., Ltd.

FJL
Class II

Oct 26, 2026

K260285

Triad Hydrophilic Wound Dresssing (1964, 2.5 oz); Triad Hydrophilic Wound Dressing (1967, 6 oz)

Coloplast Corp.

FRO
Unclassified