Company ยท US
Ambu, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2005. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 16 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 6 |
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 2 |
| DRX | Electrode, Electrocardiograph | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 2 |
| GXY | Electrode, Cutaneous | 2 |
| BSJ | Mask, Gas, Anesthetic | 1 |
| BSY | Catheters, Suction, Tracheobronchial | 1 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 1 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 |
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 1 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 4, 2005 | K051529 | AMBU NEUROLINE GROUND Ambu, Inc. | GXY |
| Nov 15, 2004 | K042682 | AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR Ambu, Inc. | BTM |
| Nov 12, 2004 | K042843 | AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS Ambu, Inc. | BTM |
| Sep 22, 2004 | K041734 | AMBU DISPOSABLE ECG ELECTRODE Ambu, Inc. | DRX |
| Jul 22, 2004 | K040991 | AMBU DISPOSABLE PRESSURE MANOMETER Ambu, Inc. | CAP |
| Jun 28, 2004 | K041026 | AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S Ambu, Inc. | DRX |
| Mar 5, 2004 | K032278 | AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE Ambu, Inc. | GXY |
| Feb 27, 2004 | K032421 | AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE Ambu, Inc. | MKJ |
| May 25, 2001 | K010583 | AMBU GEL, HYDROGEL BURN DRESSING Ambu, Inc. | MGQ |
| May 17, 2000 | K993278 | AMBU NEONATE SILICONE RESUSCITATOR Ambu, Inc. | BTM |
| Oct 25, 1999 | K992902 | AMBU HAND POWER SUCTION PUMP Ambu, Inc. | BSY |
| Apr 12, 1999 | K982722 | AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD Ambu, Inc. | CAF |
| Jul 17, 1998 | K981891 | AMBU TUBECHECK Ambu, Inc. | BTR |
| May 15, 1997 | K964584 | AMBU SPUR NEONATE Ambu, Inc. | BTM |
| May 5, 1995 | K932031 | AMBU PORTABLE SUCTION UNIT Ambu, Inc. | BTA |
| Jun 22, 1993 | K932014 | AMBU DISPOSABLE FACE MASK Ambu, Inc. | BSJ |
| Feb 5, 1993 | K923762 | SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE Ambu, Inc. | BTM |
| Jan 5, 1993 | K923976 | AMBU SINGLE PATIENT USE PEEP VALVE Ambu, Inc. | BYE |
| Sep 16, 1992 | K924216 | AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO Ambu, Inc. | BTM |
| Sep 16, 1992 | K924215 | AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR Ambu, Inc. | BTM |
| Jun 19, 1992 | K922712 | SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM Ambu, Inc. | BTM |
| Jun 19, 1992 | K922707 | SPUR ADULT WITH OPEN RESERVOIR SYSTEM Ambu, Inc. | BTM |
| Oct 7, 1991 | K914187 | AMBU SILICONE RESUSCITATOR INFANT/CHILD Ambu, Inc. | BTM |
| May 28, 1991 | K910040 | AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT Ambu, Inc. | BTM |
| May 28, 1991 | K904920 | AMBU MATIC AUTOMATIC RESUSCITATOR Ambu, Inc. | BTL |
| Jul 16, 1990 | K902261 | AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT Ambu, Inc. | BTM |
| Jun 8, 1990 | K900260 | AMBU LIFE KEY AND AMBU RES-CUE KEY Ambu, Inc. | BTM |
| Sep 14, 1988 | K883434 | AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) Ambu, Inc. | BTM |
| Sep 2, 1988 | K883433 | AMBU TWIN PUMP - (MANUAL SUCTION PUMP) Ambu, Inc. | GCY |
| Dec 30, 1987 | K873579 | AMBU RMT VALVE Ambu, Inc. | BWF |
| Apr 15, 1985 | K851194 | AMBU CPAP SYSTEM Ambu, Inc. | BYE |
| Nov 15, 1984 | K844149 | AMBU RUBEN CIRCLE ANESTHESIA SYSTEM Ambu, Inc. | CAI |
| Feb 10, 1984 | K840349 | MARK III RESUSCITATOR Ambu, Inc. | BTM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2025 | Ambu Inc. Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Re Open, Classified |
BTM | K152931 |
| May 6, 2025 | Ambu Inc. Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US Open, Classified |
EOQ | K232582 |
| Oct 30, 2024 | Ambu Inc. Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000) Open, Classified |
CBI | K203749 |
| Jan 11, 2024 | Ambu Inc. Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 Open, Classified |
EOQ | K223299 |
| Sep 22, 2023 | Ambu Inc. Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system.
Catalog No: 405011000 Open, Classified |
FEM | None listed |
| Jun 3, 2022 | Ambu Inc. Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000,
412371000,
412391000,
412411000 Open, Classified |
CBI | K203749 |
| Mar 24, 2016 | Ambu Inc. Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile
for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures. Terminated |
BTO | None listed |
| Dec 22, 2007 | Ambu Incorporated Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve Spare Part, REF 137 000 501, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 Terminated |
BYE | None listed |
| Dec 22, 2007 | Ambu Incorporated Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm connector, REF 137 001 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthi Terminated |
BYE | None listed |
| Dec 22, 2007 | Ambu Incorporated Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, REF 000 138 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-135 Terminated |
BYE | None listed |
| Dec 22, 2007 | Ambu Incorporated Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF 000 137 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 Terminated |
BYE | K782152 |