FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Anesthesiology ×
9,002 results
1–24 of 9,002
Search insights Median review: 93d Cleared: 100% Top manufacturer: Respironics, Inc. Lead specialty: Anesthesiology
Cleared Oct 02, 2026
Ninenovo Blood Oxygen Ring...
K260490 · DQA
Shenzhen Ninenovo Technology Limited
Anesthesiology · 231d
Cleared Sep 25, 2026
Profoject™ LOR Syringe
K261372 · CAZ
CMT Health PTE., Ltd.
Anesthesiology · 151d
Cleared Sep 25, 2026
Altis Full Face Mask
K261262 · BZD
Respironics, Inc.
Anesthesiology · 162d
Cleared Sep 25, 2026
Aevice Wheeze Detection Module
K260140 · PHZ
Aevice Health Pte. , Ltd.
Anesthesiology · 248d
Cleared Sep 24, 2026
Disposable Belts for Polysomnography (CNSAC)
K260949 · MNR
CNSAC Medshop GmbH
Anesthesiology · 185d
Cleared Sep 23, 2026
Portable Oxygen Concentrator (OX-1A-E, OX-1B)
K254289 · CAW
Oxytek Medical Technology Co., Ltd.
Anesthesiology · 266d
Cleared Sep 18, 2026
Mesh Nebulizer (UN204)
K254171 · CAF
Shenzhen Mericonn Technology Co., Ltd.
Anesthesiology · 269d
Cleared Sep 16, 2026
ElintMAX Respiratory Monitor (ElintMAX Monitor A1)
K260226 · BZK
Amptron Medical, Inc.
Anesthesiology · 233d
Cleared Sep 11, 2026
Venti-Trach Tracheostomy Tube (570 Series)
K253063 · BTO
Vitaltec Corporation
Anesthesiology · 354d
Cleared Sep 03, 2026
Tenax® Laser Resistant Endotracheal Tube
K251794 · BTR
Bryan Medical, Inc.
Anesthesiology · 448d
Cleared Aug 27, 2026
Optiflow Oxygen Kit (AA484J)
K262268 · BTT
Fisher and Paykel Healthcare Limited
Anesthesiology · 52d
Cleared Aug 27, 2026
EasyCare Tx 2
K261360 · MOD
ResMed Corp
Anesthesiology · 125d
Cleared Aug 24, 2026
BiWaze Clear System
K260604 · NHJ
Abmrc, LLC
Anesthesiology · 181d
Cleared Aug 20, 2026
CPETWise Platform
K260242 · BTY
Medibyt , Ltd.
Anesthesiology · 206d
Cleared Aug 20, 2026
Valence InVent Xtend™ (CVG-4101-VXA)
K253807 · MOD
Convergence Medical Sciences , Ltd.
Anesthesiology · 265d
Cleared Aug 14, 2026
Portable Oxygen Concentrator (PO1 5B, PO1 6B)
K260171 · CAW
BMC Medical Co., Ltd.
Anesthesiology · 205d
Cleared Aug 13, 2026
TrachFlush
K261499 · BSK
Aw Technologies Aps
Anesthesiology · 99d
Cleared Aug 13, 2026
BIS™ Advance pEEG Module
K260907 · OLW
Covidien LP
Anesthesiology · 147d
Cleared Aug 12, 2026
Masimo Root Monitoring System
K253417 · MWI
Masimo Corporation
Anesthesiology · 315d
Cleared Aug 12, 2026
GF-310R Multigas Unit (GF-310R)
K251641 · CCK
Nihon Kohden Corporation
Anesthesiology · 440d
Cleared Jul 31, 2026
WatchPAT SW
K254042 · MNR
Itamar Medical , Ltd.
Anesthesiology · 227d
Cleared Jul 30, 2026
PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
K261389 · CCL
Salter Labs
Anesthesiology · 93d
Cleared Jul 24, 2026
EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes
K261274 · KTI
Cook Ireland, Ltd.
Anesthesiology · 98d
Cleared Jul 23, 2026
RXiBreeze PAP System (RXiBreeze 20C)
K253044 · BZD
Resvent Medical Technology Co., Ltd.
Anesthesiology · 304d