Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Anesthesiology — Predicate Candidate Screening
8,405 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
179 daysmedian FDA review time
352 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254042 | WatchPAT SW | Itamar Medical , Ltd. | 2026-07-31 | 227 | 0 |
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | Salter Labs | 2026-07-30 | 93 | 0 |
| K253044 | RXiBreeze PAP System (RXiBreeze 20C) | Resvent Medical Technology Co., Ltd. | 2026-07-23 | 304 | 0 |
| K261011 | Sleep Apnea Feature (v2.0) | Samsung Electronics Co., Ltd. | 2026-07-20 | 116 | 0 |
| K260050 | WRAP System | Huneo, LLC | 2026-07-15 | 189 | 0 |
| K261633 | VisuBreath | Affirm Medical Technologies II, LLC | 2026-07-14 | 57 | 0 |
| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-06-25 | 268 | 0 |
| K253274 | BedDot (G1) | Intelligent Dots, LLC | 2026-06-25 | 269 | 0 |
| K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Microlife Corporation | 2026-06-23 | 270 | 0 |
| K253148 | RX-1 Sleep | Vivaquant, Inc. Dba Rhythm Express | 2026-06-22 | 270 | 0 |
| DEN250025 | Syncron-E | Autonomous Healthcare, Inc. | 2026-06-18 | 360 | 0 |
| K252066 | inspired™ Heated Breathing Circuit (510-008); inspired™ Heat | Vincent Healthcare Products Limited | 2026-06-18 | 352 | 0 |
| K252399 | Portable Oxygen Concentrator | Honsun (Nantong) Co., Ltd. | 2026-06-17 | 321 | 0 |
| K253001 | KT Airway Clearance Device II (KT-3); KT Airway Clearance De | Hunan Ruijiong Biotech Co., Ltd. | 2026-06-16 | 270 | 0 |
| K253437 | Spiro-VISTA | Spiro Robotics | 2026-06-12 | 254 | 0 |
| K251326 | Respiration Rate algorithm | Edwards Lifesciences, LLC | 2026-06-11 | 408 | 0 |
| K253553 | Orion | Resmed Corp | 2026-06-04 | 202 | 0 |
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | FindAir Sp. z o.o. | 2026-06-02 | 125 | 0 |
| K252844 | Tyto Insights for Wheeze Detection (with PCCP) | Tyto Care , Ltd. | 2026-06-02 | 267 | 0 |
| K252802 | Peak Flow Meter (PF-10(BR-PEF231)) | Shenzhen Bi-Rich Medical Devices Co., Ltd. | 2026-05-29 | 268 | 0 |
| K253119 | CoSense ETCO Monitor | Capnia, Inc. | 2026-05-29 | 247 | 0 |
| K252965 | Oxygen Concentrator (OX-5A, OX-5C) | Oxytek Medical Technology Co., Ltd. | 2026-05-29 | 254 | 0 |
| K254104 | ResScan Essentials | Resmed Corp | 2026-05-27 | 159 | 0 |
| K254102 | Glucommander | Glytec, LLC | 2026-05-27 | 159 | 0 |
| K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Acce | Senzime AB | 2026-05-22 | 50 | 0 |
| K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Ma | Dcstar, Inc. | 2026-05-21 | 332 | 0 |
| K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | Drägerwerk AG Co. Kgaa | 2026-05-21 | 265 | 0 |
| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Teleflex Medical Sdn. Bhd. | 2026-05-15 | 267 | 0 |
| K260051 | CorVision® (91-205-Z0014) | CorVent® Medical, Inc. | 2026-05-12 | 124 | 0 |
| K253647 | Evita (V800); Evita (V600) | Draegerwerk AG & CO Kgaa | 2026-05-07 | 168 | 0 |
| K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | 2026-05-01 | 224 | 0 |
| K260910 | EndoTool IV Cloud 1.0 | Glooko, Inc. | 2026-05-01 | 43 | 0 |
| K251583 | Ambu® Virobac II® Exhalation Filter | Ambu A/S | 2026-04-30 | 342 | 0 |
| K252849 | AffloVest® Mobile Airway Clearance Therapy | Tactile Medical | 2026-04-30 | 234 | 0 |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | 2026-04-29 | 215 | 0 |
| K252628 | CASSIE | Wesper, Inc. | 2026-04-27 | 250 | 0 |
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC | 2026-04-23 | 266 | 0 |
| K252338 | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | 2026-04-17 | 263 | 0 |
| K252663 | Inbentus Versatile | Iconic Solutions by Murcia, SL | 2026-04-14 | 235 | 0 |
| K254078 | HVT 2.0 | Vapotherm, Inc. | 2026-04-13 | 116 | 0 |
| K251889 | myAir | Resmed Corp | 2026-04-08 | 292 | 0 |
| K252182 | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-04-06 | 269 | 0 |
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC | 2026-03-26 | 132 | 0 |
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / | Medline Industries, LP | 2026-03-25 | 176 | 0 |
| K251950 | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-03-20 | 268 | 0 |
| K252078 | BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc. | 2026-03-17 | 258 | 0 |
| K251584 | Medical Mesh Nebulizer (AirICU Max+) | AIRICU, Inc. | 2026-03-12 | 293 | 0 |
| K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | 2026-03-12 | 265 | 0 |
| K251777 | MESI mTABLET SPIRO | Mesi D.O.O. | 2026-03-02 | 265 | 0 |
| K251661 | Mariana Minerva; Mariana Nimbus | Resmed Pty , Ltd. | 2026-02-23 | 269 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda