510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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BMC Medical Co., Ltd.

Fengtai District Beijing, CN

BMC MEDICAL CO., LTD. appears in FDA device records in Fengtai District Beijing, CN. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 7 510(k) clearances for BMC Medical Co., Ltd. between 2014 and 2026. The busiest year on record is 2022, with 2. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for BMC Medical Co., Ltd., by decision year
YearClearances
20141
20171
20222
20251
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)CAWSubstantially Equivalent
K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BZDSubstantially Equivalent
K242935Respiration Data Management Software (PAP Link PC)BZDSubstantially Equivalent
K213169BPAP SystemMNSSubstantially Equivalent
K211155Auto CPAP SystemBZDSubstantially Equivalent
K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)BZDSubstantially Equivalent
K133009NASAL MASK, NASAL MASK, FULL FACE MASKBZDSubstantially Equivalent

Registered establishments

FDA registered establishments for BMC Medical Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30085661323008566132BMC MEDICAL CO., LTD.Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road, Fengtai District Beijing 100073 CN2026

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
RecallProductReasonClassificationInitiatedStatus
Z-2979-2026BMC/REACTHEALTH Luna G3 APAP REF LG 3600Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouseClass IOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain