FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Anesthesiology ×
8,982 results
1–24 of 8,982
Search insights Median review: 92d Cleared: 100% Top manufacturer: Respironics, Inc. Lead specialty: Anesthesiology
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 · FCG
Cook Ireland, Ltd.
Anesthesiology · 98d
Cleared Jul 23, 2026
RXiBreeze PAP System (RXiBreeze 20C)
K253044 · BZD
Resvent Medical Technology Co., Ltd.
Anesthesiology · 304d
Cleared Jul 20, 2026
Sleep Apnea Feature (v2.0)
K261011 · QZW
Samsung Electronics Co., Ltd.
Anesthesiology · 116d
Cleared Jul 14, 2026
VisuBreath
K261633 · CCK
Affirm Medical Technologies II, LLC
Anesthesiology · 57d
Cleared Jul 10, 2026
SedLine Sedation Monitor
K260880 · OLW
Masimo Corporation
Anesthesiology · 115d
Cleared Jul 10, 2026
LungFlow Airway Catheter
K254037 · EOQ
Free Flow Medical, Inc.
Anesthesiology · 206d
Cleared Jun 25, 2026
A5 Anesthesia System (A5)
K253330 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 268d
Cleared Jun 25, 2026
BedDot (G1)
K253274 · BZQ
Intelligent Dots, LLC
Anesthesiology · 269d
Cleared Jun 23, 2026
Microlife Digital Peak Flow Meter, Model PF200B (PF200B)
K253180 · BZH
Microlife Corporation
Anesthesiology · 270d
Cleared Jun 22, 2026
RX-1 Sleep
K253148 · MNR
Vivaquant, Inc. Dba Rhythm Express
Anesthesiology · 270d
Cleared Jun 18, 2026
inspired™ Heated Breathing Circuit (510-008)
K252066 · BZE
Vincent Healthcare Products Limited
Anesthesiology · 352d
Not Cleared Jun 18, 2026
Syncron-E
DEN250025 · QVC
Autonomous Healthcare, Inc.
Anesthesiology · 360d
Cleared Jun 17, 2026
Portable Oxygen Concentrator
K252399 · CAW
Honsun (Nantong) Co., Ltd.
Anesthesiology · 321d
Cleared Jun 16, 2026
KT Airway Clearance Device II (KT-3)
K253001 · NHJ
Hunan Ruijiong Biotech Co., Ltd.
Anesthesiology · 270d
Cleared Jun 12, 2026
Spiro-VISTA
K253437 · BTR
Spiro Robotics
Anesthesiology · 254d
Cleared Jun 11, 2026
Respiration Rate algorithm
K251326 · BZQ
Edwards Lifesciences, LLC
Anesthesiology · 408d
Cleared Jun 04, 2026
Orion
K253553 · BZD
ResMed Corp
Anesthesiology · 202d
Cleared Jun 02, 2026
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
K260270 · CAF
FindAir Sp. z o.o.
Anesthesiology · 125d
Cleared Jun 02, 2026
Tyto Insights for Wheeze Detection (with PCCP)
K252844 · PHZ
Tyto Care , Ltd.
Anesthesiology · 267d
Cleared Jun 01, 2026
VisionAir Enhanced Stock Stent
K261541 · NWA
VisionAir Solutions
Anesthesiology · 24d
Cleared May 29, 2026
CoSense ETCO Monitor
K253119 · CCJ
Capnia, Inc.
Anesthesiology · 247d
Cleared May 29, 2026
Oxygen Concentrator (OX-5A, OX-5C)
K252965 · CAW
Oxytek Medical Technology Co., Ltd.
Anesthesiology · 254d