510(k) · Cleared
Recalled · Class I · 20230.9% 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
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nurse Assist, LLC · NGT Saline, Vascular Access Flush
Cleared on Aug 11, 2020 as substantially equivalent to K171109 (Medxl, Inc., 2017) after an 89-day review. Its family tree reaches back 3 generations to 2005. 1 of the 5 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Aug 11, 2020
- Review
- 89 days
- Class
- Class II
- Product code
- NGT
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to K053120 (2005). 1 later device descends from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK053120 Sterile Field Saline and Heparin Lock Flush SyringesExcelsior Medical Corp. · 2005 · Recalled
- 2 generations backK082837 Sterile Field Saline Pre-Filled Syringe (S)Excelsior Medical Corp. · 2008 · Recalled
- 1 generation backK171109 Praxiject 0.9% NaClMedxl, Inc. · 2017
- This deviceK201286 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1…Nurse Assist, LLC · 2020
- Descendant · cites it directly · 0 of its ownK243484 PM2+ System and SmartPICC StyletPiccolo Medical, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K053120 | Sterile Field Saline and Heparin Lock Flush Syringes | Excelsior Medical Corp. | 2005 | 1 |
| −2 | K082837 | Sterile Field Saline Pre-Filled Syringe (S) | Excelsior Medical Corp. | 2008 | 1 |
| −1 | K171109 | Praxiject 0.9% NaCl | Medxl, Inc. | 2017 | — |
| 0 (this device) | K201286 | 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch… | Nurse Assist, LLC | 2020 | — |
| +1 | K243484 | PM2+ System and SmartPICC Stylet | Piccolo Medical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NGT device
- #1 K250884 0.9 % Sodium Chloride Injection, USP, BD…score 11.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K171109 | Praxiject 0.9% NaClSummary page 4…NGT Device Classification II III. Predicate Device Substantial equivalence is claimed to the following devices: • Praxiject™ 0.9% NaCl, K171109, MedXL Inc. The following reference device is cited within the submission: • Normal Saline Flush, K150143, Nurse Assis… | 2017 |
| † | K150143 | Normal Saline Flush | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243484 | PM2+ System and SmartPICC Stylet | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2023 | Class I | Z-0512-2024 | Process control | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. |
| Nov 6, 2023 | Class I | Z-0511-2024 | Process control | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K243484 (Piccolo Medical, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K171109.
How does its category compare?
All NGT devicesNGT Saline, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NGT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGT
142in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGT
1in 2025
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · NGT
212in 2025
MAUDE reports naming product code NGT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 31 |
| 2008 | 1 | — | 0 | 64 |
| 2009 | 1 | — | 1 | 18 |
| 2010 | 2 | — | 7 | 23 |
| 2011 | 3 | 219 | 1 | 20 |
| 2012 | 4 | 106 | 1 | 5 |
| 2013 | 1 | — | 1 (1) | 25 |
| 2014 | 3 | 87 | 0 | 25 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 1 | — | 1 (1) | 82 |
| 2017 | 2 | — | 0 | 56 |
| 2018 | 1 | — | 0 | 270 |
| 2019 | 2 | — | 2 | 340 |
| 2020 | 2 | — | 0 | 322 |
| 2021 | 0 | — | 1 (1) | 566 |
| 2022 | 3 | 151 | 1 | 282 |
| 2023 | 6 | 142 | 3 (2) | 313 |
| 2024 | 1 | — | 0 | 332 |
| 2025 | 1 | — | 1 | 212 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations for the appropriate device. May be placed on a sterile field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201286: 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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201286
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026