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

Jiangyin Jiangsu, CN

JIANGSU CAINA MEDICAL CO., LTD appears in FDA device records in Jiangyin Jiangsu, CN. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
15
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 15 510(k) clearances for Jiangsu Caina Medical Co., Ltd between 2018 and 2024. The busiest year on record is 2021, with 4. The most recent is 2024, with 2.

Clearances by year, as a table
510(k) clearance decisions for Jiangsu Caina Medical Co., Ltd, by decision year
YearClearances
20182
20192
20203
20214
20221
20231
20242
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232781Safety Sliding Blood Collection SetJKASubstantially Equivalent
K233190ENFit AdaptorPIOSubstantially Equivalent
K230635Pen NeedleFMISubstantially Equivalent
K220184Pump Alignment SyringeFMFSubstantially Equivalent
K211593Enteral Pump SyringePNRSubstantially Equivalent
K210217Needleless ConnectorFPASubstantially Equivalent
K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetPTISubstantially Equivalent
K201356Plastic LOR SyringeCAZSubstantially Equivalent
K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample AdapterJKASubstantially Equivalent
K193022Retractable Safety Insulin SyringeMEGSubstantially Equivalent
K193526Syringe with safety needle, Safety needleFMFSubstantially Equivalent
K191490Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy SyringeMEGSubstantially Equivalent
K190502ENFit Oral / Enteral SyringePNRSubstantially Equivalent
K181374NRFit SyringeQEHSubstantially Equivalent
K172938Disposable Sterile NeedleFMISubstantially Equivalent

Registered establishments

FDA registered establishments for Jiangsu Caina Medical Co., Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30056702213005670221JIANGSU CAINA MEDICAL CO., LTDNo.23, Huanxi Road, Zhutang Town, Jiangyin Jiangsu 214415 CN2026and 10 more, listed in full below

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

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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