Atlas FDA

Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe

FDA 510(k) clearance K232943 · decided 2024-05-31

Clearance details

K-number
K232943
Device name
Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe
Applicant
Smiths Medical Asd, Inc.
Decision
Substantially Equivalent
Date received
2023-09-20
Decision date
2024-05-31
Days to decision
254 days
Clearance type
Traditional
Product code
QNQ
Device class
2
Regulation number
880.5860
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Plymouth, MN, 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
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe (K252814)CMT Health PTE., Ltd.2026-02-19
TSK Syringe (K250127)Tsk Laboratory, Japan2025-07-30
Small Volume 0.2mL Syringe (K250138)Prosum Medical Limited2025-04-02
SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle (K242291)Sol-Millennium Medical, Inc.2024-11-20
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe (K241190)Poonglim Pharmatech, Inc.2024-05-29
TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) (K231856)Medexel Co.,Ltd2024-03-15
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe (K221860)Poonglim Pharmatech, Inc.2023-09-15
FEELject LDV (Low dead volume) syringe (K213010)Feeltech Co., Ltd.2023-05-31
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe (K213013)Jeil Tech Co., Ltd.2022-09-19
LDV((Low Dead Volume )Syringe (K220083)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2022-05-25
PLPT LDV (Low Dead Volume) Sterile Syringe (K210443)Poonglim Pharmatech, Inc.2021-02-16

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S018)Smiths Medical Asd, Inc.2013-05-13
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S017)Smiths Medical Asd, Inc.2010-04-21
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S016)Smiths Medical Asd, Inc.2009-04-20
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S015)Smiths Medical Asd, Inc.2007-11-06
PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S014)Smiths Medical Asd, Inc.2007-08-28
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S013)Smiths Medical Asd, Inc.2007-04-05
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM (P900052/S012)Smiths Medical Asd, Inc.2002-12-17
PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S011)Smiths Medical Asd, Inc.2002-10-03