Ambu Limited
Registered establishment in Xiang Yu F.T.Z., Xiamen, Fujian, China. 11 device types, 33 clearances.
Ambu Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Orthosis, Cervical and 9 other device types. Its earliest product listing with the FDA dates from 2003.
11device types registered with the FDA
33510(k) clearances
11recalls
Registration
| Registered name | AMBU Limited |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3003924186 |
| FEI number | 3003924186 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Xiang Yu F.T.Z., Xiamen |
|---|---|
| Province | Fujian |
| Address | No.C, |
| Postal code | 361006 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Ambu AuraOnce, Ambu AuraFlex, Ambu Aura-i, Ambu Laryngeal Mask, Ambu AuraGain, Ambu AuraStraight and 1 more | 2003 | 84 |
| Attachment, Breathing, Positive End Expiratory Pressure | Class 2 | Ambu Reusable PEEP valve, Ambu PEEP Valve, Airlife PEEP Valve, Ambu PEEP 20 Valve | 2008 | 9 |
| Cardiopulmonary Resuscitation Aid Kit | Class 2 | Ambu® SPUR® II, Ambu® Mark IV | 2024 | 3 |
| Laryngoscope, Rigid | Class 1 | Ambu® SureSight® Battery Charger, Ambu® SureSight® Mobile, Ambu® aView™ 2 Advance, Ambu® aBox™ 2, Ambu® SureSight® Blade Hyperangulated Channeled, Ambu® SureSight® Connect and 4 more | 2013 | 44 |
| Mask, Gas, Anesthetic | Class 1 | Ambu King Mask | 2005 | 71 |
| Mask, Oxygen | Class 1 | Ambu Silicone Face Mask, Ambu Disposable Face Mask | 2006 | 126 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | Class 2 | Ambu Disposable Pressure Manometer | 2008 | 7 |
| Orthosis, Cervical | Class 1 | Ambu Redi Ace Adult, Ambu Mini Perfit Ace, Ambu Perfit, Ambu Perfit Ace, Ambu Redi Ace Mini | 2005 | 114 |
| Support, Patient Position | Class 1 | Ambu Head Wedge, Head Wedge, Ambu Disposable Head Immobilizer | 2006 | 66 |
| Tubing, Pressure And Accessories | Class 1 | Gas sampling lines with filter, Gas sampling lines | 2025 | 45 |
| Ventilator, Emergency, Manual (Resuscitator) | Class 2 | Ambu Mark IV Baby Resuscitator, Mark IV, Ambu Mark IV Resuscitator, Ambu Spur II | 2009 | 8 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K051529 | 2005-08-04 | GXY | Traditional | This company |
| K042682 | 2004-11-15 | BTM | Traditional | This company |
| K042843 | 2004-11-12 | BTM | Traditional | This company |
| K041734 | 2004-09-22 | DRX | Traditional | This company |
| K040991 | 2004-07-22 | CAP | Traditional | This company |
| K041026 | 2004-06-28 | DRX | Traditional | This company |
| K032278 | 2004-03-05 | GXY | Traditional | This company |
| K032421 | 2004-02-27 | MKJ | Traditional | This company |
| K010583 | 2001-05-25 | MGQ | Traditional | This company |
| K993278 | 2000-05-17 | BTM | Traditional | This company |
| K992902 | 1999-10-25 | BSY | Traditional | This company |
| K982722 | 1999-04-12 | CAF | Traditional | This company |
| K981891 | 1998-07-17 | BTR | Traditional | This company |
| K964584 | 1997-05-15 | BTM | Traditional | This company |
| K932031 | 1995-05-05 | BTA | Traditional | This company |
| K932014 | 1993-06-22 | BSJ | Traditional | This company |
| K923762 | 1993-02-05 | BTM | Traditional | This company |
| K923976 | 1993-01-05 | BYE | Traditional | This company |
| K924215 | 1992-09-16 | BTM | Traditional | This company |
| K924216 | 1992-09-16 | BTM | Traditional | This company |
| K922707 | 1992-06-19 | BTM | Traditional | This company |
| K922712 | 1992-06-19 | BTM | Traditional | This company |
| K914187 | 1991-10-07 | BTM | Traditional | This company |
| K910040 | 1991-05-28 | BTM | Traditional | This company |
| K904920 | 1991-05-28 | BTL | Traditional | This company |
| K902261 | 1990-07-16 | BTM | Traditional | This company |
| K900260 | 1990-06-08 | BTM | Traditional | This company |
| K883434 | 1988-09-14 | BTM | Traditional | This company |
| K883433 | 1988-09-02 | GCY | Traditional | This company |
| K873579 | 1987-12-30 | BWF | Traditional | This company |
| K851194 | 1985-04-15 | BYE | Traditional | This company |
| K844149 | 1984-11-15 | CAI | Traditional | This company |
| K840349 | 1984-02-10 | BTM | Traditional | This company |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-07-09 | Class I | Equipment maintenance | Potential for the manometer port being blocked rendering the manometer non-functional. | 87,156 units | |
| 2025-04-07 | Class II | Process control | Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states | 160 units | |
| 2024-09-16 | Class II | Under Investigation by firm | Ambu has received complaints on Ambu VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and potential airway injury. | 1824 | |
| 2023-12-05 | Class II | Device Design | Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the lithium-ion battery | 11845 distributed US | |
| 2023-07-21 | Class II | Device Design | Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device combust leading to smoke and flames | 2689 units | |
| 2022-06-03 | Class II | Under Investigation by firm | Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient. | 12,921 | |
| 2016-02-10 | Class II | Process control | Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovered the problem during final quality control at manufacturing site. Damage to the sterile barrier (the pouch) may compromise a medical device’s | Total Numbers of unit distributed: 45990 pes (USA) | 2016-06-22 |
| 2007-08-21 | Not classified | Process design | Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration. | 197 total | 2008-06-16 |
| 2007-08-21 | Not classified | Process design | Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration. | 197 total | 2008-06-16 |
| 2007-08-21 | Not classified | Process design | Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration. | 197 total | 2008-06-16 |
| 2007-08-21 | Not classified | Process design | Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration. | 197 total | 2008-06-16 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1937 |
|---|---|
| Main products | manual resuscitators, Ambu bags, anesthesia masks, CPR masks, ventilator breathing circuits |
| Export markets | global |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.