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Anesthesiology devices
199 product codes reviewed by the Anesthesiology panel. 8,426 510(k) clearances and 3,296 recalls in the FDA data, 57% of those recalls name a 510(k).
96510(k)s in 12 months
183recalls in 12 months
1,885recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 336 | 23 |
| BTR | Tube, Tracheal (W/Wo Connector) | 227 | 1 |
| CAZ | Anesthesia Conduction Kit | 220 | 13 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 205 | 14 |
| BSZ | Gas-Machine, Anesthesia | 177 | 12 |
| JOH | Tube Tracheostomy And Tube Cuff | 131 | 5 |
| BSO | Catheter, Conduction, Anesthetic | 119 | 2 |
| CAC | Apparatus, Autotransfusion | 114 | 0 |
| BRY | Cabinet, Table And Tray, Anesthesia | 99 | 10 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 98 | 0 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 97 | 1 |
| BSY | Catheters, Suction, Tracheobronchial | 89 | 0 |
| BZD | Ventilator, Non-Continuous (Respirator) | 83 | 3 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 76 | 3 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 73 | 1 |
Active product codes
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 2 | 4 | 23 |
| OFT | Spinal Epidural Anesthesia Kit | 2 | 0 | 16 |
| BZD | Ventilator, Non-Continuous (Respirator) | 2 | 12 | 3 |
| BSZ | Gas-Machine, Anesthesia | 2 | 2 | 12 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 0 | 14 |
| CAW | Generator, Oxygen, Portable | 2 | 12 | 2 |
| CAZ | Anesthesia Conduction Kit | 2 | 1 | 13 |
| NHJ | Device, Positive Pressure Breathing, Intermittent | 2 | 2 | 12 |
| BRY | Cabinet, Table And Tray, Anesthesia | 1 | 0 | 10 |
| OGJ | Nerve Block Tray | 2 | 0 | 9 |
| NDC | Calculator, Drug Dose | 2 | 5 | 3 |
| OGE | Epidural Anesthesia Kit | 2 | 0 | 8 |
| MNR | Ventilatory Effort Recorder | 2 | 6 | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 5 | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 2 | 1 | 5 |
| BZA | Connector, Airway (Extension) | 1 | 0 | 4 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 2 | 1 | 3 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 4 | 0 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | 2 | 3 | 1 |
| MOD | Accessory To Continuous Ventilator (Respirator) | 2 | 3 | 1 |
| OFR | Tracheobronchial Suction Catheter Kit | 1 | 0 | 4 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 | 2 | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 | 2 | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 0 | 3 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 | 2 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 3 | 0 |
| ECX | Cylinder, Compressed Gas, And Valve | 1 | 0 | 3 |
| OFU | Spinal Anesthesia Kit | 2 | 0 | 3 |
| BSK | Cuff, Tracheal Tube, Inflatable | 2 | 1 | 1 |
| BSO | Catheter, Conduction, Anesthetic | 2 | 0 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 2 | 1 | 1 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 2 | 2 | 0 |
| BZH | Meter, Peak Flow, Spirometry | 2 | 2 | 0 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 0 | 2 |
| BZQ | Monitor, Breathing Frequency | 2 | 2 | 0 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 2 | 0 | 2 |
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 2 | 2 | 0 |
| CBT | Arterial Blood Sampling Kit | 1 | 0 | 2 |
| MRN | Apparatus, Nitric Oxide Delivery | 2 | 0 | 2 |
| NXA | Tracheotomy Care Kit | 2 | 0 | 2 |
| OFQ | Anesthesia Kit | 2 | 0 | 2 |
| OGD | Custom Anesthesia Tray | 2 | 0 | 2 |
| PHZ | Abnormal Breath Sound Device | 2 | 2 | 0 |
| SGR | Noninvasive Positive Airway Pressure System, Facility Use | 2 | 2 | 0 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 2 | 0 | 1 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 2 | 1 | 0 |
| BWC | Needle, Emergency Airway | 2 | 0 | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 2 | 0 | 1 |
| BYG | Mask, Oxygen | 1 | 0 | 1 |
| BYI | Percussor, Powered-Electric | 2 | 1 | 0 |
| BZG | Spirometer, Diagnostic | 2 | 1 | 0 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 2 | 1 | 0 |
| CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | 2 | 1 | 0 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 2 | 1 | 0 |
| CCX | Support, Patient Position | 1 | 0 | 1 |
| KOI | Stimulator, Nerve, Peripheral, Electric | 2 | 1 | 0 |
| MNT | Continuous, Minimal Ventilatory Support, Facility Use Ventilator | 2 | 1 | 0 |
| NOU | Continuous, Ventilator, Home Use | 2 | 0 | 1 |
| OGG | Humidifier Nebulizer Kit | 2 | 0 | 1 |
| OGI | Nasal Endotracheal Tube Holder Kit | 1 | 0 | 1 |
| QVC | Ventilator Waveform Analysis Software | 2 | 1 | 0 |
| QZW | Over-The-Counter Device To Assess Risk Of Sleep Apnea | 2 | 1 | 0 |
| SFP | Ventilator-Compatible Nebulizer | 2 | 1 | 0 |
| SHJ | Thrombectomy Whole Blood Return System | 2 | 1 | 0 |
Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2026 | NATUS MEDICAL INCORPORATED Embletta MPR PG Multi Parameter Recorder Sleep Monitor, Model/Catalog Number: 2003011 Open, Classified |
MNR | K122516 |
| Oct 22, 2026 | Medtronic MiniMed, Inc. Generic Name: MiniMed Go App
Generic Name: MiniMed Go App
Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android)
Software Version: Software version 1.2.1
Product Description: The MiniMed Go app for Open, Classified |
NDC | K253512 |
| Oct 20, 2026 | Ventec Life Systems, Inc. V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support. Open, Classified |
CBK | None listed |
| Oct 20, 2026 | Ventec Life Systems, Inc. V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VC(Japan)
Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VC
Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. V+Pro
Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001, Package PN: N/A; Model Number: PRT-01185-002, Package PN:N/A. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VCSN+Pro
Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VOCSN (Japan)
Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VOCSN
Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VC+Pro (Japan)
Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VC+Pro
Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VOCSN+Pro (Japan),
Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VOCSN+Pro,
Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 9, 2026 | Sarnova HC, Llc Curaplex Capnography
EtCO2/O2 Oral/Nasal Cannula
Multipack (10 pk), Item Number
670272-KIT Open, Classified |
CCX | None listed |
| Oct 1, 2026 | Draeger, Inc. VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310
Disposable breathing circuit for use with a resuscitation module. Open, Classified |
BYE | K092029 |
| Oct 1, 2026 | Custom Interventional Pain Management, LLC Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM
Product Name: Mastisol Skin Adhesive
Model/Catalog Number: 24161B (Ferndale and Medline); Tray 17025 17g continuo Open, Classified |
OGE | None listed |
| Sep 28, 2026 | Percussionaire Corporation Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC Open, Classified |
NHJ | None listed |
| Sep 28, 2026 | Percussionaire Corporation Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual Open, Classified |
NHJ | None listed |
| Sep 28, 2026 | Percussionaire Corporation Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual Open, Classified |
NHJ | None listed |
| Sep 28, 2026 | Percussionaire Corporation Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual Open, Classified |
NHJ | None listed |
| Sep 28, 2026 | Percussionaire Corporation Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual Open, Classified |
NHJ | None listed |
| Sep 28, 2026 | Percussionaire Corporation In-Line Valve, Product Number: P5-TEE Open, Classified |
MOD | None listed |
| Sep 28, 2026 | Percussionaire Corporation Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instruction Manual Open, Classified |
NHJ | None listed |
| Sep 25, 2026 | NOXBOX LTD NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I. Open, Classified |
MRN | K171696 K201339 +3 |
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