Data / Medical devices / Denmark / Ambu A/S
Ambu A/S: FDA-registered device maker in Ballerup Hovedstaden, Denmark, 37 510(k) clearances
Ambu A/S is registered with the FDA (registration 9610691) in Ballerup Hovedstaden, Denmark. It lists 28 device types. The FDA files 37 510(k) clearances under its listings, the newest dated September 16, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9610691
- FEI number
- 3002806359
- Address
- Baltorpbakken 13, Ballerup Hovedstaden, Denmark, DK-2750
- Owner or operator
- AMBU A/S (8010067)
- Roles
- Exporter to the US, Foreign private label distributor, Specification developer
- First device listed
- December 8, 2003
- Registered through
- 2027
- Brand names listed
- AMBU DISPOSABLE HEAD IMMOBILIZER, AMBU HEAD WEDGE, AMBU LARYNGEAL MASK, Airlife PEEP Valve, Ambu Aura-i, Ambu Aura40, Ambu AuraFlex, Ambu AuraGain and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2026 | K261400 | Ambu® aScope Gastro; Ambu® aScope Gastro Large | FDS | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| September 16, 2026 | K260309 | Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | EOQ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| June 11, 2025 | K250269 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection) | FAJ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| October 16, 2024 | K240849 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2 | FAJ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| October 10, 2024 | K240848 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance | FAJ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| August 16, 2024 | K242108 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance | FGB | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| June 24, 2024 | K233630 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aBox 2 | FGB | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| April 16, 2024 | K233886 | Ambu® aScope Duodeno 2, Ambu® aBox 2 | FDT | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| April 5, 2024 | K232919 | Ambu® aScope Gastro Large; Ambu® aBox 2 | FDS | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| January 4, 2024 | K233671 | Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance | EOQ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| September 20, 2023 | K232582 | Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | EOQ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| August 10, 2023 | K230428 | Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2 | EOQ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| June 1, 2023 | K223299 | Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance | EOQ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| January 12, 2023 | K223782 | Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set | EOQ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| July 25, 2022 | K220606 | Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 | EOQ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| February 3, 2022 | K212382 | Ambu® aScope Gastro, Ambu® aBox2 | FDS | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| June 17, 2021 | K210883 | aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 | EOQ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| May 3, 2021 | K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable | CBI | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| April 2, 2020 | K193095 | Ambu aScope 4 Cysto | FAJ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| July 12, 2019 | K190972 | Ambu aScope 4 RhinoLaryngo Intervention | EOB | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| May 22, 2019 | K191080 | Ambu aScope 4 RhinoLaryngo Slim | EOB | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| March 28, 2018 | K173727 | Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor | EOQ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| August 29, 2016 | K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator | BTM | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| January 13, 2010 | K093825 | AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE | IKT | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| July 30, 2007 | K071186 | MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE | IKT | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| May 30, 2007 | K071185 | MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE | GXZ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| December 23, 2005 | K053140 | AMBU MARK IV RESUSCITATOR | BTM | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| December 20, 2005 | K053142 | AMBU MARK IV BABY RESUSCITATOR | BTM | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| August 4, 2005 | K051529 | AMBU NEUROLINE GROUND | GXY | Substantially Equivalent | Ambu, Inc. | accessdata.fda.gov |
| July 22, 2004 | K040991 | AMBU DISPOSABLE PRESSURE MANOMETER | CAP | Substantially Equivalent | Ambu, Inc. | accessdata.fda.gov |
| March 5, 2004 | K032278 | AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE | GXY | Substantially Equivalent | Ambu, Inc. | accessdata.fda.gov |
| June 14, 2002 | K020907 | NEUROLINE, SUBDERMAL NEEDLE ELECTRODES | IKT | Substantially Equivalent | Medicotest A/S | accessdata.fda.gov |
| May 15, 1997 | K970639 | NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K | GXY | Substantially Equivalent | Medicotest, Inc. | accessdata.fda.gov |
| December 21, 1993 | K931430 | CUTANEOUS ELECTRODE | GXY | Substantially Equivalent | Medicotest, Inc. | accessdata.fda.gov |
| December 21, 1993 | K931426 | NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODE | GXY | Substantially Equivalent | Medicotest, Inc. | accessdata.fda.gov |
| January 5, 1993 | K923976 | AMBU SINGLE PATIENT USE PEEP VALVE | BYE | Substantially Equivalent | Ambu, Inc. | accessdata.fda.gov |
| December 26, 1978 | K782152 | VALVE, AMBU PEEP | BYE | Unknown | Narco Air-Shields | accessdata.fda.gov |
Compare with other makers
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Laryngoscope Kit
- All makers of Orthosis, Cervical
- All makers of Attachment, Breathing, Positive End Expiratory Pressure
- All makers of Airway, Oropharyngeal, Anesthesiology
- All makers of Ventilator, Emergency, Manual (Resuscitator)
Updated September 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.