Skip to content

Aerobika

by Trudell Medical International

Ref 110501510(k) K150173

Aerobika (110501) is a medical device (EU MDR Class I; FDA Class II; FDA product code BWF; EMDN category respiratory and anaesthesia devices) made by Trudell Medical International, registered in EUDAMED on 30 Mar 2022 (Basic UDI-DI 762860OPEP1G4) and cleared under FDA 510(k) K150173 on 15 Oct 2015, active as of 25 Oct 2026.

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150173↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number762860OPEP1G4 Basic UDI-DI 00762860100022UDI-DIDate30 Mar 2022RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK150173 Date15 Oct 2015ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 762860OPEP1G4 registered 30 Mar 2022 Active
  • FDA 510(k) K150173 decided 15 Oct 2015 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K150173
  2. Registered EUDAMED 762860OPEP1G4

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device name
Aerobika* Oscillating Positive Expiratory Pressure Device
Model / reference
110501
Primary DI / UDI-DI
00762860100022
Basic UDI-DI
762860OPEP1G4
510(k) Number
FDA product code
BWF
EMDN code
R9099 Respiratory and anaesthesia devices - other
Device class
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 868.5690
EU registration type
Standard device
EU market of registration
Türkiye
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class I
510(k)
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Manufacturer details

EUDAMED SRN
CA-MF-000009860
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Pulmonary function analysis system, adult

Similar devices in this category

Other devices filed under RESPIRATORY AND ANAESTHESIA DEVICES - OTHER.

Other devices from Trudell Medical International

See all devices from Trudell Medical International →

Properties

Other properties (14, all answered No)