510(k) Report

FDA applicant

Ambu A/S

Ballerup, DK41 decisions2005–20265 recalls

FDA records 41 decisions for Ambu A/S (Ballerup, DK) from 2005 to 2026: 41 510(k) clearances. Most are in product codes EOQ (Bronchoscope (Flexible Or Rigid)) and FAJ (Cystoscope And Accessories, Flexible/Rigid). Since 2016 its 510(k)s took a median of 142 days from receipt to decision, against 160 for FDA’s reviews in the same codes and years. Its devices cite 67 predicates, 30 of them its own earlier devices. 5 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Ambu A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 22010: 32011: 22013: 12016: 32018: 22019: 22020: 12021: 22022: 22023: 52024: 72025: 12026 (partial year): 4
2007high 7 (2024) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2025

2022: 12023: 12024: 12025: 2, 1 Class I
2007high 2 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ambu A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EOQBronchoscope (Flexible Or Rigid)11decisions
  • FAJCystoscope And Accessories, Flexible/Rigid5decisions
  • BTMVentilator, Emergency, Manual (Resuscitator)4decisions
  • FDSGastroscope And Accessories, Flexible/Rigid3decisions
  • DRXElectrode, Electrocardiograph3decisions
  • EOBNasopharyngoscope (Flexible Or Rigid)3decisions

Also: FGB (2), BTR (2), IKT (2), CBI (1), FDF (1), FDT (1).

How long do its 510(k) reviews take?

Since 2016, its 22 510(k)s took a median of 142 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 160 days; 12 of its 22 were faster than that.

Whose devices does it build on?

Its devices cite 67 predicates; 30 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 81 times; 30 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K173727Ambu 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…Ambu A/S · 201816cite it
  • K193095Ambu aScope 4 CystoAmbu A/S · 202010cite it
  • K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 AdvanceAmbu A/S · 20234cite it
  • K191080Ambu aScope 4 RhinoLaryngo SlimAmbu A/S · 20194cite it
  • K230332Ambu® aScope™ Colon; Ambu® aBox™ 2Ambu A/S · 20234cite it
  • K130845Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S · 20134cite it

What has FDA decided for it lately?

  • K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S · 2026
  • K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S · 2026
  • K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup…Ambu A/S · 2026
  • K251583Ambu® Virobac II® Exhalation FilterAmbu A/S · 2026
  • K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)Ambu A/S · 2025
  • K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2Ambu A/S · 2024
  • K240848Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™…Ambu A/S · 2024
  • K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2…Ambu A/S · 2024

All 41 as Ambu A/S →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K152931Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog…Jul 9, 2025Class I
  • K232582Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000USApr 7, 2025Class II
  • K203749Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr…Sep 16, 2024Class II
  • K223299Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2Dec 5, 2023Class II
  • K203749Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and…Jun 3, 2022Class II

Other applicant names beginning “Ambu”

FDA records each applicant name separately; these may or may not be the same firm.

Ambu, Inc. 33Ambu Innovation GmbH 1