| Endotracheal Tube (K190274) | Tianjin Medis Medical Device Co., Ltd. | 2019-07-30 |
| Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented (K190533) | Sleepnet Corporation | 2019-07-26 |
| Trilogy Evo (K181166) | Respironics, Inc. | 2019-07-18 |
| Trilogy Evo Universal (K181170) | Respironics, Inc. | 2019-07-18 |
| DROWZLE (K173974) | Resonea, Inc. | 2019-07-14 |
| Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask (K190254) | Sleepnet Corporation | 2019-07-05 |
| Hudson RCI Voldyne Volumetric Exerciser (K182847) | Teleflexmedical, Inc. | 2019-07-01 |
| Maxxi Rip Sensor (K171304) | Neurovirtual USA, Inc. | 2019-06-24 |
| Hailie Sensor (K182638) | Adherium (Nz), Ltd. | 2019-06-19 |
| Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 (K190663) | PAJUNK GmbH Medizintechnologie | 2019-06-17 |
| Hailie Sensor (K182573) | Adherium (Nz), Ltd. | 2019-06-07 |
| ComPAS2 (Computerized Pulmonary Analysis System) (K190568) | Morgan Scientific, Inc. | 2019-06-06 |
| WatchPAT ONE (K183559) | Itamar Medical , Ltd. | 2019-06-05 |
| MaxCap Ped and MaxCap Neo (K182362) | Maxtec, LLC | 2019-05-23 |
| WiZARD 310/320 Series CPAP Mask (K182394) | Apex Medical Corp. | 2019-05-17 |
| VPC (K190345) | PAJUNK GmbH Medizintechnologie | 2019-05-16 |
| Moore Park Mask (K183512) | Resmed, Ltd. | 2019-05-07 |
| CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO (K183394) | GE Healthcare Finland Oy | 2019-05-01 |
| NS 120P-TRS Airway Pressure Gauge (K180510) | Instrumentation Industries, Inc. | 2019-05-01 |
| Ascent Cardiorespiratory Diagnostic Software (K181912) | Medical Graphics Corporation | 2019-04-12 |
| OJR215 Pressure Relief Manifold (K173770) | Fisher & Paykel Healthcare Limited | 2019-04-05 |
| ToxCO (K173238) | Bedfont Scientific, Ltd. | 2019-04-04 |
| Shiley Neonatal/Pediatric Tracheostomy Tube (K182861) | Covidien | 2019-03-22 |
| Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line (K181624) | Oridion Medical 1987 , Ltd. | 2019-03-22 |
| SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 (K180098) | Maquet Critical Care AB | 2019-03-19 |
| Medline Reinforced Epidural Catheter (K181782) | Medline Industries, Inc. | 2019-03-04 |
| XactTrace Single Use Respiratory Effort Belt System (K173793) | Embla Systems | 2019-03-01 |
| SpiroSphere (K173937) | Eresearchtechnology GmbH | 2019-02-15 |
| Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line (K181467) | Oridion Medical 1987 , Ltd. | 2019-02-08 |
| CO2 Sampling Line (K181981) | Tylenol Medical Instruments Co., Ltd. | 2019-02-06 |
| d-Nav System (K181916) | Hygieia, Inc. | 2019-02-04 |
| Accucuff Cuff Pressure Indicator (K182548) | Tianjin Medis Medical Device Co., Ltd. | 2019-01-25 |
| Puffin Lite Infant Resuscitation System (K182956) | International Biomedical | 2019-01-18 |
| Savina 300 (K180779) | Dragerwerk AG & CO Kgaa | 2019-01-17 |
| MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly (K180902) | Medipines Corporation | 2019-01-11 |
| AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) (K181649) | Trudell Medical International | 2019-01-11 |
| CONTEC Oxygen Concentrator (K180837) | Contec Medical System Co., Ltd. | 2019-01-10 |
| Care Orchestrator (K181053) | Respironics, Inc. | 2019-01-04 |
| Enlight 1810 (DEN170072) | Timpel, Inc. | 2018-12-20 |
| O2 Concepts Oxlife Independence Model 301-0001 (K182454) | O2 Concepts, LLC | 2018-12-20 |
| AirSpiral Heated Breathing Tube (K162553) | Fisher & Paykel Healthcare | 2018-12-20 |
| Retrograde Intubation Set (DEN170055) | Cook Incorporated | 2018-12-12 |
| Hailie Sensor (K181405) | Adherium (Nz), Ltd. | 2018-12-10 |
| CATSmart (K180831) | Fresenius Kabi AG | 2018-12-10 |
| Nihon Kohden NKV-550 Series Ventilator System (K181695) | Nihon Kohden Orangemed, Inc. | 2018-12-07 |
| Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 (K181583) | Flexicare Medical Limited. | 2018-12-07 |
| Transcend 365 miniCPAP System (K180388) | Somnetics International, Inc. | 2018-11-30 |
| Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART (K181524) | Vyaire Medical, Inc. | 2018-11-30 |
| VivaSight-SL (TVT) system (K181880) | Etview , Ltd. | 2018-11-29 |
| MATRx Plus (K181996) | Zephyr Sleep Technologies | 2018-11-21 |
| SafeT T-Piece Resuscitator (K173373) | Ventlab, LLC | 2018-11-16 |
| VivaSight-DL System (K181886) | Etview , Ltd. | 2018-11-14 |
| Sheridan Endobronchial Tubes (K180253) | Teleflex Medical | 2018-11-02 |
| Peak.me (K180487) | Breathe Me, Ltd. | 2018-10-26 |
| Monarch Airway Clearance System (K173603) | Hill-Rom Holdings, Inc. | 2018-10-24 |
| Gas Module 3 (K180788) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-10-24 |
| TNI softFlow 50 (K180474) | Tni Medical AG | 2018-10-18 |
| AG 100s (K180991) | Hospitech Respiration , Ltd. | 2018-10-12 |
| NOxBOXi Nitric Oxide Delivery System (K171696) | Praxair Distribution, Inc. | 2018-10-02 |
| PeDIA (K181424) | Pedia, LLC | 2018-09-25 |
| EndoTool SubQ (K180366) | Al Pacheco and Associates | 2018-09-20 |
| Portable Nebulizer (K180871) | Microbase Technology Corporation | 2018-09-14 |
| Masimo Acoustic Respiration Sensors, infant and neonate (K173976) | Masimo Corporation | 2018-09-05 |
| Intelligent Mesh Nebulizer (K171549) | Qingdao Future Medical Technology Co., Ltd. | 2018-08-31 |
| Equinox Advantage (K173205) | O-Two Medical Technologies, Inc. | 2018-08-29 |
| EPINAUT (K173541) | Imedicom Co., Ltd. | 2018-08-24 |
| autoLog IQ Autotransfusion System (K181954) | Medtronic Perfusion Systems | 2018-08-22 |
| VersaPAP Positive Airway Pressure (PAP) Device (K173918) | Trudell Medical International | 2018-08-17 |
| Watch-PAT300 (K180775) | Itamar Medical , Ltd. | 2018-08-17 |
| F&P SleepStyle (K173193) | Fisher & Paykel Healthcare, Ltd. | 2018-08-08 |
| Neonatal ConchaSmart Breathing Circuits (K173280) | Teleflexmedical, Inc. | 2018-08-02 |
| Propeller Sensor for Neohaler (K180770) | Reciprocal Labs Corporation | 2018-08-01 |
| Smart One (K181666) | Mir Medical International Research | 2018-08-01 |
| Smartinhaler (K180407) | Adherium (Nz), Ltd. | 2018-07-25 |
| TV-100 (K173973) | Bio-Med Devices, Inc. | 2018-07-20 |
| Capnograph and Oximeter (K170820) | Cmi Health, Inc. | 2018-07-18 |
| Pulmonx Chartis Tablet Console (K180011) | Pulmonx Corporation | 2018-07-13 |
| InPen Dose Calculator (K181327) | Companion Medical, Inc. | 2018-07-06 |
| HOMED Mesh Nebulizer (K170886) | Shenzhen Homed Medical Device Co., Ltd. | 2018-06-21 |
| SuperNO2VA Et Device (K173147) | Revolutionary Medical Devices, Inc. | 2018-06-20 |
| Scone Mask (K180497) | Resmed, Ltd. | 2018-06-15 |
| Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors (K172800) | Smiths Medical Asd, Inc. | 2018-06-14 |
| Portex NRFit Epidural Needles (K172823) | Smiths Medical Asd, Inc. | 2018-06-12 |
| Pakter Curved Needle Set (K173155) | Cook Incorporated | 2018-06-07 |
| Curve Positive Airway Pressure System (DEN170089) | Fresca Medical | 2018-06-05 |
| Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters (K172410) | Smiths Medical Asd, Inc. | 2018-06-01 |
| Oxygen Concentrator (K172234) | Sysmed (China) Co., Ltd. | 2018-06-01 |
| ETCO2 Sensor (K171828) | Orantech, Inc. | 2018-05-31 |
| ToFscan (K172690) | Idmed | 2018-05-31 |
| VORTRAN Cuff Inflator (VCI) (K173914) | Vortran Medical Technology 1, Inc. | 2018-05-25 |
| GRAFTSITE (K173110) | Summit Medical , Ltd. | 2018-05-18 |
| Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer (K170663) | Foremount Enterprise Co., Ltd. | 2018-05-11 |
| BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube (K173912) | Smiths Medical Asd, Inc. | 2018-05-08 |
| Weinmann Tracheostomy Exchange Set (K180034) | Cook Incorporated | 2018-05-07 |
| Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation (K180079) | Hill-Rom, Inc. | 2018-05-07 |
| Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 (K172777) | PAJUNK GmbH Medizintechnologie | 2018-05-03 |
| Accu O2 Oxygen Analyzer (K173807) | Precision Medical, Inc. | 2018-05-02 |
| MC 300R* Nebulizer (K173825) | Trudell Medical International | 2018-05-02 |
| Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable (K171678) | Vyaire Medical, Inc. | 2018-04-30 |
| TRACOE silcosoft Tracheostomy Tube (K172720) | Tracoe Medical GmbH | 2018-04-27 |