0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
FDA 510(k) clearance K191378 · decided 2019-09-15
Clearance details
- K-number
- K191378
- Device name
- 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
- Applicant
- Medline Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-05-23
- Decision date
- 2019-09-15
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- NGT
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Northfiled, 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.
| Record | Firm | Date |
|---|
| 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (K250884) | Becton, Dickinson and Company | 2025-12-02 |
| 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 Company | 2023-07-21 |
| 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, LLC | 2020-08-11 |
| Praxiject 0.9% NaCl (K192414) | Medxl, Inc. | 2020-02-13 |
Recalls involving this device
No recalls on record reference this clearance.