Breas Medical AB

N Billerica, MA, US

BREAS MEDICAL AB appears in FDA device records in N Billerica, MA. FDA records list 16 510(k) clearances between 2006-03-16 and 2025-05-20, no PMA records and 3 registered establishments. As of 2026-09-10, FDA records show 7 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 16
PMA records: 0
Recall records: 7
Registered establishments: 3

FDA records under these names

1 name

FDA records resolved to Breas Medical AB carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Human Design Medical, LLC510(k), enforcement report, recall

510(k) clearance history

FDA records hold 16 510(k) clearances for Breas Medical AB between 2006 and 2025. The busiest year on record is 2006, with 5. The most recent is 2025, with 3.

Clearances by year, as a table

510(k) clearance decisions for Breas Medical AB, by decision year
Year	Clearances
2006	5
2007	1
2008	1
2009	1
2014	1
2016	1
2021	1
2024	2
2025	3

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K242485	EveryWare	MOD	Substantially Equivalent	2025-05-20
K242438	Clearo	NHJ	Substantially Equivalent	2025-05-16
K233452	Vivo 45 LS	NOU	Substantially Equivalent	2025-01-13
K240779	Vivo 3	MNT	Substantially Equivalent	2024-12-13
K240778	Vivo 1, Vivo 2	MNS	Substantially Equivalent	2024-12-13
K193586	Vivo 45 LS	NOU	Substantially Equivalent	2021-01-27
K160481	Vivo 60	NOU	Substantially Equivalent	2016-11-09
K140929	Z1 CPAP SYSTEM	BZD	Substantially Equivalent	2014-10-17
K090113	BREAS VIVO 40 SYSTEM	MNT	Substantially Equivalent	2009-05-14
K071702	BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40	MNT	Substantially Equivalent	2008-02-15
K063476	BREAS ISLEEP 20I	BZD	Substantially Equivalent	2007-01-22
K060657	ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.	BZD	Substantially Equivalent	2006-08-18
K061057	BREAS ISLEEP 20+	BZD	Substantially Equivalent	2006-06-23
K060546	BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30	MNS	Substantially Equivalent	2006-05-26
K060790	BREAS, MODEL HA01	BTT	Substantially Equivalent	2006-05-25
K053607	BREAS VIVO 40 SYSTEM	MNT	Substantially Equivalent	2006-03-16

Registered establishments

FDA registered establishments for Breas Medical AB, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
9617566	3003244771	BREAS MEDICAL AB	FORETAGSVAGEN 1, MOLNLYCKE Vastra Gotaland 435 33 SE	2026	BTT BZO CAI CBK CCK DQA FOX MNS MNT MOD and 2 more, listed in full below
3010817335	3010817335	BREAS MEDICAL, INC.	16 Esquire Road, N Billerica, MA 01862 US	2026	BTT BYP BZD CAI CBK CCK DQA FOX MNS MNT and 3 more, listed in full below
3020562909	3020562909	Breas Medical Ltd	Unit A2, The Bridge Business Centre, Stratford-upon-Avon Warwickshire CV379HW GB	2026	NHJ

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2690-2024	Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)	There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.	Class I	2024-07-25	Open, Classified
Z-0405-2024	with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.	Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation	Class II	2023-10-13	Open, Classified
Z-1382-2022	Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier	A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained	Class II	2022-06-02	Open, Classified
Z-0943-2022	Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384	Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity	Class II	2022-03-21	Terminated
Z-1352-2020	Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during transportation, and in hospital, institutional, and home care environments. It can be used while the Vivo ventilators is operating, for example mounted on a wheelchair, in a personal vehicle, or carried by hand. The device is not to be used with the protective cover while positioned in a warm place, such as in direct sunlight or close to a radiator. The protective cover includes the following features: transparent window for accessing front panel and buttons; port for patient circuit, cables, O2 inlet, and standby button; cooling air inlet; patient air inlet; straps for safe mounting; and cooling air outlet.	The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.	Class II	2020-01-28	Terminated
Z-2530-2018	Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation	Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.	Class III	2018-05-08	Terminated
Z-2094-2015	Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care	Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipment connected to the Vivo 50 will stop functioning as the device enters stand-by mode.	Class II	2014-11-07	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain