FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMSafe(R) Pre-Filled Normal Saline Flush Syringe
K Number: K183473
·
Decision Jul 12, 2019
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
39
Applicant Total
28
Review Days
210
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AMSafe(R) Pre-Filled Normal Saline Flush Syringe
- K Number
- K183473
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Amsino International, Inc.
- Date Received
- December 14, 2018
- Decision Date
- July 12, 2019
- Product Code
- NGT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NGT | Saline, Vascular Access Flush | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NGT), ordered by most recent decision date.
0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Praxiject SP 0.9% NaCl
FDA 510(k)
FDA Class 2
·General Hospital
Flush Syringe (Prefilled 0.9% normal saline solution)
FDA 510(k)
FDA Class 2
·General Hospital
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
FDA 510(k)
FDA Class 2
·General Hospital
Pre-Filled Normal Saline Flush Syringe
FDA 510(k)
FDA Class 2
·General Hospital
TK Pre-Filled Normal Saline Flush Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Amsino International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) | May 4, 2026 | Substantially Equivalent |
| K220230 | AMSure Enteral Feeding Pump | Nov 10, 2022 | Substantially Equivalent |
| K220267 | AMSafe NeuFlo Needleless Connector | Oct 7, 2022 | Substantially Equivalent |
| K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe | Mar 22, 2022 | Substantially Equivalent |
| K200051 | PUGGLE Enteral Feeding Pump and Feeding Set | Sep 25, 2020 | Substantially Equivalent |
| K181445 | AMSure Hydrophilic Intermittent Catheter | Oct 1, 2018 | Substantially Equivalent |
| K181423 | AMSure Sterile Water, and Sterile Normal Saline for Wound Flush | Sep 7, 2018 | Substantially Equivalent |
| K173665 | AMSafe Sure-Lok Needle-Free Connector | Sep 5, 2018 | Substantially Equivalent |
| K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water | Sep 4, 2018 | Substantially Equivalent |
| K171857 | AMSure® Enteral Feeding Syringe with ENFit Tip | Mar 30, 2018 | Substantially Equivalent |