FDA product code NGT: Saline, Vascular Access Flush
NGT is the FDA product code for saline, vascular access flush. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel. FDA has cleared 40 510(k) submissions under NGT, 10 in the last five years, from 23 different applicants. The average 510(k) review took 164 days (median 146); 180 days on average over the last three years. FDA has posted 61 recalls for NGT devices, 9 initiated in the last five years.
Definition
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Classification
| Field | Value |
|---|---|
| Device name | Saline, Vascular Access Flush |
| Device class | Class II |
| Regulation | 21 CFR 880.5200 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for NGT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 246 |
| 2018 | 1 | 239 |
| 2019 | 2 | 162 |
| 2020 | 2 | 126 |
| 2022 | 2 | 172 |
| 2023 | 6 | 134 |
| 2024 | 1 | 106 |
| 2025 | 1 | 253 |
Compare with all 510(k) review times · Search every NGT clearance
Top NGT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Becton, Dickinson and Company | 5 | 2025-12-02 |
| Medxl, Inc. | 4 | 2024-02-27 |
| Am USA | 4 | 2014-08-13 |
| Medefil, Inc. | 4 | 2012-09-20 |
| Amsino International, Inc. | 2 | 2022-03-22 |
18 more applicants have NGT clearances. See the full list in Caduvo.
Most recent NGT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250884 | Becton, Dickinson and Company | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe | 2025-12-02 | 253 |
| K233623 | Medxl, Inc. | Praxiject SP 0.9% NaCl | 2024-02-27 | 106 |
| K231724 | Spm Medicare Pvt. , Ltd. | Flush Syringe (Prefilled 0.9% normal saline solution) | 2023-11-09 | 149 |
| K231363 | Hantech Medical Device Co., Ltd. | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) | 2023-09-27 | 139 |
| K230756 | Anhui Tiankang Medical Technology Co., Ltd. | TK Pre-Filled Normal Saline Flush Syringe | 2023-08-12 | 145 |
Recalls for NGT devices
61 product recalls in 30 recall events; 9 initiated in the last five years and 12 still open. Most recent: 2026-07-06.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 4 |
| 2022 | 3 |
| 2023 | 4 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code NGT?
NGT is the FDA product code for saline, vascular access flush. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel.
What device class is NGT?
Class II, regulation 21 CFR 880.5200. Typical premarket route: 510(k).
How long does a 510(k) take for product code NGT?
Across 40 cleared submissions the average was 164 days from receipt to decision (median 146).
Which companies have the most NGT clearances?
Becton, Dickinson and Company (5); Medxl, Inc. (4); Am USA (4); Medefil, Inc. (4); Amsino International, Inc. (2).
Have NGT devices been recalled?
Yes: 61 product recalls across 30 recall events; the most recent began 2026-07-06.
Next steps
- Run an FDA pathway report with predicate devices for product code NGT
- Run a recall and safety report across every NGT manufacturer
- Watch product code NGT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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