Atlas FDA

MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE

FDA 510(k) clearance K032438 · decided 2004-06-30

Clearance details

K-number
K032438
Device name
MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
Applicant
Tyco Healthcare
Decision
Substantially Equivalent
Date received
2003-08-07
Decision date
2004-06-30
Days to decision
328 days
Clearance type
Traditional
Product code
NGT
Device class
2
Regulation number
880.5200
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mansfield, MA, 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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0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (K250884)Becton, Dickinson and Company2025-12-02
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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
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 888 recall (Z-2178-2013)Covidien LLC2013-09-10
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID: 8881 recall (Z-2179-2013)Covidien LLC2013-09-10
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Product ID: 8881 recall (Z-2180-2013)Covidien LLC2013-09-10
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID:88815801 recall (Z-2181-2013)Covidien LLC2013-09-10
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 88815801 recall (Z-2182-2013)Covidien LLC2013-09-10
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 88815801 recall (Z-2183-2013)Covidien LLC2013-09-10
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 888159 recall (Z-2184-2013)Covidien LLC2013-09-10
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590 recall (Z-2185-2013)Covidien LLC2013-09-10
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590 recall (Z-2186-2013)Covidien LLC2013-09-10
MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 10 ml in 12 ml syringe Item c recall (Z-0564-2011)Covidien LP2010-12-09
MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 3 ml in 12 ml syringe Item co recall (Z-0565-2011)Covidien LP2010-12-09
MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 5 ml in 12 ml syringe Item co recall (Z-0566-2011)Covidien LP2010-12-09
MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 10 ml in 12 ml syringe Item recall (Z-0567-2011)Covidien LP2010-12-09
MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 3 ml in 12 ml syringe Item c recall (Z-0568-2011)Covidien LP2010-12-09
MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 5 ml in 12 ml syringe Item c recall (Z-0569-2011)Covidien LP2010-12-09
Tyco HealthcareMonoject Prefill 10U/mL Heparin Lock Flush Syringe, 3mL REF # 8881580123, T recall (Z-1595-2008)Covidien LP2008-05-09
Tyco Healthcare Tyco HealthcareMonoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL REF recall (Z-1596-2008)Covidien LP2008-05-09
Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 2.5mL in 3mL syringe RE recall (Z-1597-2008)Covidien LP2008-05-09
Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL, with BLUNTIP plast recall (Z-1598-2008)Covidien LP2008-05-09
Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 10mL REF # 8881590121, recall (Z-1599-2008)Covidien LP2008-05-09
Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 3rnL REF # 8881590123, recall (Z-1600-2008)Covidien LP2008-05-09
Tyco Healthcare Monoject Prefill 100UlmL Heparin Lock Flush Syringe 5mL, with BLUNTIP plas recall (Z-1602-2008)Covidien LP2008-05-09