Atlas FDA

0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE

FDA 510(k) clearance K042061 · decided 2004-08-26

Clearance details

K-number
K042061
Device name
0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE
Applicant
Becton Dickinson
Decision
Substantially Equivalent
Date received
2004-08-02
Decision date
2004-08-26
Days to decision
24 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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Devices cleared under the same product code - the starting set for predicate research.

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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
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. recall (Z-0025-2015)Navilyst Medical, Inc2014-10-07
BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, recall (Z-0026-2015)Navilyst Medical, Inc2014-10-07
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. recall (Z-0027-2015)Navilyst Medical, Inc2014-10-07
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. recall (Z-0028-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, recall (Z-0029-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, recall (Z-0030-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, recall (Z-0031-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL L recall (Z-0032-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, recall (Z-0033-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN Prod recall (Z-0034-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL L recall (Z-0035-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, recall (Z-0036-2015)Navilyst Medical, Inc2014-10-07
0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306 recall (Z-2670-2014)Centurion Medical Products Corporation2014-09-19