# Ambu A/S

- Location (FDA's records): Ballerup, DK
- FDA decisions: 41 (2005–2026): 41 510(k) clearances
- Product codes: EOQ (11), FAJ (5), BTM (4), FDS (3), DRX (3), EOB (3), FGB (2), BTR (2), IKT (2), CBI (1), FDF (1), FDT (1)
- 510(k) review time since 2016: median 142 days, against 160 for FDA's reviews in the same codes and years (12 of 22 faster)
- Predicates its devices cite: 67 (30 its own); citations of its devices by later devices: 81 (30 its own)
- Recalls linked to its devices: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Olympus Medical Systems Corp.: 5 (https://510kreport.com/company/olympus-medical-systems)
- Olympus Optical Co., Ltd.: 5 (https://510kreport.com/company/olympus-optical)
- Ambu, Inc.: 4 (https://510kreport.com/company/ambu)
- Medicotest, Inc.: 2 (https://510kreport.com/company/medicotest)
- Etview, Ltd.: 2 (https://510kreport.com/company/etview)
- Olympus America, Inc.: 2 (https://510kreport.com/company/olympus-america)
- Vision-Sciences, Inc.: 2 (https://510kreport.com/company/vision-sciences)
- Medicotest A/S: 2 (https://510kreport.com/company/medicotest-a-s)

## Firms that cite its devices most
- Hunan Vathin Medical Instrument Co., Ltd.: 9 (https://510kreport.com/company/hunan-vathin-medical-instrument)
- Shenzhen HugeMed Medical Technical Development Co., Ltd.: 3 (https://510kreport.com/company/shenzhen-hugemed-medical-technical-development)
- Medimaging Integrated Solution, Inc (Miis): 3 (https://510kreport.com/company/medimaging-integrated-solution-miis)
- Verathon Medical (Canada) Ulc: 2 (https://510kreport.com/company/verathon-medical-canada-ulc)
- MacroLux Medical Technology Co., Ltd.: 2 (https://510kreport.com/company/macrolux-medical-technology)
- Spes Medica Srl: 2 (https://510kreport.com/company/spes-medica)
- Zhuhai Wesee Meditech Co., Ltd.: 2 (https://510kreport.com/company/zhuhai-wesee-meditech)
- Shanghai AnQing Medical Instrument Co., Ltd.: 2 (https://510kreport.com/company/shanghai-anqing-medical-instrument)

## Its most-cited devices
- 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 (2018), cited by 16
- K193095: Ambu aScope 4 Cysto (2020), cited by 10
- K223299: Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance (2023), cited by 4
- K191080: Ambu aScope 4 RhinoLaryngo Slim (2019), cited by 4
- K230332: Ambu® aScope™ Colon; Ambu® aBox™ 2 (2023), cited by 4
- K130845: Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview (2013), cited by 4

## Recent decisions
- 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 (Sep 16, 2026)
- K261400: Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large (Sep 16, 2026)
- K260578: Ambu® NeurolineTM Cup MRI/CT  (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set  (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set  (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US) (Jul 14, 2026)
- K251583: Ambu® Virobac II® Exhalation Filter (Apr 30, 2026)
- K250269: Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) (Jun 11, 2025)
- K240849: Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 (Oct 16, 2024)
- K240848: Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance (Oct 10, 2024)
- K242108: Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance (Aug 16, 2024)

Source page: https://510kreport.com/company/ambu-a-s