Atlas FDA

0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe

FDA 510(k) clearance K161552 · decided 2017-02-02

Clearance details

K-number
K161552
Device name
0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe
Applicant
Becton, Dickinson and Company
Decision
Substantially Equivalent
Date received
2016-06-06
Decision date
2017-02-02
Days to decision
241 days
Clearance type
Special
Product code
NGT
Device class
2
Regulation number
880.5200
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Franklin Lakes, NJ, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (K250884)Becton, Dickinson and Company2025-12-02
Praxiject™ SP 0.9% NaCl (K233623)Medxl, Inc.2024-02-27
Flush Syringe (Prefilled 0.9% normal saline solution) (K231724)Spm Medicare Pvt. , Ltd.2023-11-09
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) (K231363)Hantech Medical Device Co., Ltd.2023-09-27
TK Pre-Filled Normal Saline Flush Syringe (K230756)Anhui Tiankang Medical Technology Co., Ltd.2023-08-12
Pre-Filled Normal Saline Flush Syringe (K223584)Anhui Tianyang Pharmaceutical Co., Ltd.2023-08-12
0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe (K231161)Becton, Dickinson and Company2023-07-21
Praxiject™ 0.9% NaCl (K231754)Medxl, Inc.2023-07-13
Pentaflush (K214080)Pentaferte Italia S.R.L.2022-07-20
AMSafe Pre-Filled Normal Saline Flush Syringe (K213522)Amsino International, Inc.2022-03-22
0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch (K201286)Nurse Assist, LLC2020-08-11
Praxiject 0.9% NaCl (K192414)Medxl, Inc.2020-02-13

Recalls involving this device

RecordFirmDate
PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL recall (Z-0736-2024)Becton Dickinson & Company2024-01-17

PMA approvals by this applicant

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BD Onclarity HPV Assay (P160037/S025)Becton, Dickinson and Company2026-04-02
BD FOX™ PCR Extraction Tubes; BD Onclarity™ HPV Assay (P160037/S026)Becton, Dickinson and Company2026-02-12
BD ONCLARITY HPV ASSAY (P160037/S022)Becton, Dickinson and Company2025-08-25
BD Onclarity HPV Assay (P160037/S023)Becton, Dickinson and Company2025-07-02
Onclarity HPV Assay (P160037/S021)Becton, Dickinson and Company2025-03-12
BD Onclarity™ HPV Assay (P160037/S020)Becton, Dickinson and Company2024-11-05
BD Onclarity HPV Assay (P160037/S017)Becton, Dickinson and Company2024-05-14