3B Medical Inc

Dublin, OH, US

3B MEDICAL INC appears in FDA device records in Dublin, OH. FDA records list 10 510(k) clearances between 2013-08-22 and 2022-03-25, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show 3 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 10
PMA records: 0
Recall records: 3
Registered establishments: 2

510(k) clearance history

FDA records hold 10 510(k) clearances for 3B Medical Inc between 2013 and 2022. The busiest year on record is 2013, with 3. The most recent is 2022, with 1.

Clearances by year, as a table

510(k) clearance decisions for 3B Medical Inc, by decision year
Year	Clearances
2013	3
2014	1
2015	1
2016	2
2020	1
2021	1
2022	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K212263	Luna G3 BPAP System	BZD	Substantially Equivalent	2022-03-25
K201620	Luna® G3 BPAP 25A	BZD	Substantially Equivalent	2021-01-29
K200496	Aer X	CAW	Substantially Equivalent	2020-07-24
K160127	iCodeConnect	BZD	Substantially Equivalent	2016-11-10
K153387	Luna CPAP and Auto CPAP System	BZD	Substantially Equivalent	2016-09-08
K141770	LUNA CPAP AND AUTO-CPAP SYSTEM	BZD	Substantially Equivalent	2015-04-22
K133769	3B RESMART BPAP 25A, BMC RESMART BPAP 25A	BZD	Substantially Equivalent	2014-08-25
K131901	IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2	BZD	Substantially Equivalent	2013-12-23
K132967	3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP	BZD	Substantially Equivalent	2013-12-06
K131707	3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS	BZD	Substantially Equivalent	2013-08-22

Registered establishments

FDA registered establishments for 3B Medical Inc, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3042507287	3042507287	3B MEDICAL INC	1054 Gateway Park Dr, W Jefferson, OH 43162 US	2026	BTT BZD CAT CAW MNS
3009096682	3009096682	3B Medical Inc	5475 Rings Road, Dublin, OH 43017 US	2026	BZD CAW DQA MNS

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-1815-2026	React Health PHOENIX 5L Oxygen Concentrator	Devices which did not meet internal quality specifications were inadvertently distributed.	Class II	2026-02-04	Open, Classified
Z-0828-2025	Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators	The devices were inadvertently shipped after their expiration date.	Class II	2024-11-27	Open, Classified
Z-2740-2026	Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal pillows interface intended for use with positive airway pressure therapy devices. The device delivers airflow from a PAP device to the patient's nose and is secured using adjustable headgear. Component: No	Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).	Class II	2023-06-15	Open, Classified

Verification record

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