Atlas FDA

FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE

FDA 510(k) clearance K090882 · decided 2010-04-23

Clearance details

K-number
K090882
Device name
FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE
Applicant
Hospira, Inc.
Decision
Substantially Equivalent
Date received
2009-03-31
Decision date
2010-04-23
Days to decision
388 days
Clearance type
Traditional
Product code
NGT
Device class
2
Regulation number
880.5200
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Lake Forest, IL, 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
Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Proced recall (Z-0663-2013)Merit Medical Systems, Inc.2013-01-10
0.9% Sodium Chloride Injection, USP, pre-filled flush solution, for IV Flush only, sterile recall (Z-0596-2012)Hospira Inc.2012-01-11
Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use recall (Z-0035-2011)Excelsior Medical Corp2010-10-20

PMA approvals by this applicant

RecordFirmDate
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S008)Hospira, Inc.1999-01-29
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S007)Hospira, Inc.1996-09-05
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S006)Hospira, Inc.1996-01-04
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S003)Hospira, Inc.1995-12-15
DEXTRAN HM 32 (P880028/S002)Hospira, Inc.1990-11-15
DEXTRAN HM 32 (P880028/S001)Hospira, Inc.1989-12-29
DEXTRAN HM 32% (P880028)Hospira, Inc.1989-05-30