Atlas FDA

AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE

FDA 510(k) clearance K113555 · decided 2012-01-30

Clearance details

K-number
K113555
Device name
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
Applicant
Am USA
Decision
Substantially Equivalent
Date received
2011-12-01
Decision date
2012-01-30
Days to decision
60 days
Clearance type
Special
Product code
NGT
Device class
2
Regulation number
880.5200
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Nashville, TN, 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.

RecordFirmDate
0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (K250884)Becton, Dickinson and Company2025-12-02
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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
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; recall (Z-1174-2024)MRP, LLC dba Aquabiliti2024-02-22