# Ambu, Inc.

- Location (FDA's records): Linthicum, MD
- FDA decisions: 33 (1984–2005): 33 510(k) clearances
- Product codes: BTM (15), GXY (2), BYE (2), DRX (2), MGQ (1), CAP (1), BWF (1), BTA (1), CAI (1), BTR (1), CAF (1), BTL (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 24 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medicotest A/S: 1 (https://510kreport.com/company/medicotest-a-s)

## Firms that cite its devices most
- Hersill, S.L.: 5 (https://510kreport.com/company/hersill)
- Ambu A/S: 4 (https://510kreport.com/company/ambu-a-s)
- Flexicare Medical Limited.: 3 (https://510kreport.com/company/flexicare-medical)
- Monica Healthcare, Ltd.: 1 (https://510kreport.com/company/monica-healthcare)
- Medela AG: 1 (https://510kreport.com/company/medela)
- Hsiner Co., Ltd.: 1 (https://510kreport.com/company/hsiner)
- Microbvm Systems, Ltd.: 1 (https://510kreport.com/company/microbvm-systems)
- Ives Eeg Solutions, Inc.: 1 (https://510kreport.com/company/ives-eeg-solutions)

## Its most-cited devices
- K042682: Ambu Spur II. Adult Single Patient Resuscitator (2004), cited by 4
- K040991: Ambu Disposable Pressure Manometer (2004), cited by 3
- K032278: Ambu Neuroline Single Patient Eeg/EP Cup Electrode (2004), cited by 3
- K042843: Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators (2004), cited by 3
- K923976: Ambu Single Patient Use Peep Valve (1993), cited by 2
- K010583: Ambu Gel, Hydrogel Burn Dressing (2001), cited by 1

## Recent decisions
- K051529: Ambu Neuroline Ground (Aug 4, 2005)
- K042682: Ambu Spur II. Adult Single Patient Resuscitator (Nov 15, 2004)
- K042843: Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators (Nov 12, 2004)
- K041734: Ambu Disposable Ecg Electrode (Sep 22, 2004)
- K040991: Ambu Disposable Pressure Manometer (Jul 22, 2004)
- K041026: Ambu Blue Sensor, MRX, Ecg Electrode Product #:MRX-00-S (Jun 28, 2004)
- K032278: Ambu Neuroline Single Patient Eeg/EP Cup Electrode (Mar 5, 2004)
- K032421: Ambu Pediatric Multi-Function Defibrillation Electrode (Feb 27, 2004)

Source page: https://510kreport.com/company/ambu