Hamilton-BC8010 260185: CE/MDR Class IIb

Regulatory status

as of registry sync 9 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number76300028PN2601853D Basic UDI-DI	Date2 Sep 2026Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK163283	Date20 Sep 2017Decided	StatusActive
United States	GUDID listing GUDID	Number07630002800846 UDI-DI	Date4 Oct 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK152029	Date3 May 2016Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 76300028PN2601853D — open Devices and search for it
AccessGUDID record UDI-DI 07630002800846
FDA 510(k) database 510(k) number K163283
FDA 510(k) database 510(k) number K152029

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 76300028PN2601853D registered 2 Sep 2026 Active
FDA 510(k) K163283 decided 20 Sep 2017 Active· +1 more in the status table
FDA GUDID UDI-DI 07630002800846 listed 4 Oct 2016 Listed

Recalls

1 recall · FDA

- Completed Z-1385-2022 FDA Class III initiated 5 Jan 2021 on shared 510(k) K163283
When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

3 May 2016 Cleared FDA 510(k) K152029
4 Oct 2016 Listed FDA GUDID 07630002800846
20 Sep 2017 Cleared FDA 510(k) K163283
5 Jan 2021 Recall initiated FDA recalls Z-1385-2022
2 Sep 2026 Registered EUDAMED 76300028PN2601853D

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: HAMILTON-BC8010,breathing circuit set dual limb, heated, with water chamber EUDAMED
Hamilton-BC8010 GUDID
Generic name: Ventilator breathing circuit, single-use
Model / Ref / Catalog: 260185

Primary DI / UDI-DI: 07630002800846, 17630002800843
Basic UDI-DI: 76300028PN2601853D
510(k) Number: K152029
K163283
FDA product code: BZE
EMDN code: R060201 Active ventilation humidification systems,
GMDN term: Ventilator breathing circuit, single-use

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 868.5270
EU registration type: Standard device
EU market of registration: Austria
GUDID distribution status: In Commercial Distribution

MRI safety: MR Unsafe

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIb	GUDID Class II

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