510(k) · Cleared
Recalled · Class II · 2022Sterile Field Saline Pre-Filled Syringe (S)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excelsior Medical Corp. · NGT Saline, Vascular Access Flush
Cleared on Dec 18, 2008 as substantially equivalent to K053120 (Excelsior Medical Corp., 2005) after an 83-day review. Its family tree reaches back 1 generation to 2005. 1 of the 11 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it. It has been recalled once.
- Decided
- Dec 18, 2008
- Review
- 83 days
- Class
- Class II
- Product code
- NGT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053120 (2005). 9 later devices descend from it, 3 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK053120 Sterile Field Saline and Heparin Lock Flush SyringesExcelsior Medical Corp. · 2005 · Recalled
- This deviceK082837 Sterile Field Saline Pre-Filled Syringe (S)Excelsior Medical Corp. · 2008
- Descendant · cites it directly · 6 of its ownK171109 Praxiject 0.9% NaClMedxl, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK192414 Praxiject 0.9% NaClMedxl, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK231754 Praxiject™ 0.9% NaClMedxl, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK201286 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1…Nurse Assist, LLC · 2020 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK243484 PM2+ System and SmartPICC StyletPiccolo Medical, Inc. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K201286 0.9% Sodium Chloride I.V. Flush Syringe for…2 generations on · 2020
Most influential descendants
Showing 5 of 9 · See all- K171109Praxiject 0.9% NaClMedxl, Inc. · 2017 · cites it directly6descendants
- K192414Praxiject 0.9% NaClMedxl, Inc. · 2020 · 2 generations on3descendants
- K231754Praxiject™ 0.9% NaClMedxl, Inc. · 2023 · 3 generations on1descendant
- K2012860.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9%…Nurse Assist, LLC · 2020 · 2 generations on1descendant
- K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053120 | Sterile Field Saline and Heparin Lock Flush Syringes | Excelsior Medical Corp. | 2005 | 1 |
| 0 (this device) | K082837 | Sterile Field Saline Pre-Filled Syringe (S) | Excelsior Medical Corp. | 2008 | — |
| +1 | K171109 | Praxiject 0.9% NaCl | Medxl, Inc. | 2017 | — |
| +2 | K192414 | Praxiject 0.9% NaCl | Medxl, Inc. | 2020 | — |
| +3 | K231754 | Praxiject™ 0.9% NaCl | Medxl, Inc. | 2023 | — |
| +2 | K201286 | 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch… | Nurse Assist, LLC | 2020 | Class I |
| +3 | K243484 | PM2+ System and SmartPICC Stylet | Piccolo Medical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K053120 | Sterile Field Saline and Heparin Lock Flush SyringesSummary page 1…s claimed to the following devices: * Excelsior Medical Heparin Lock Flush Syringe (1 U/mL and 2 U/mL) * Excelsior Sterile Field Saline Flush Syringe (K053120) Description of the Device The Excelsior Medical Saline pre-filled Syringe(s) in Sterile Field Packaging will contain 10ml of 0.… | 2005 |
| * | — | Excelsior Medical Heparin Lock Flush Syringe (1 U/mL and 2 U/mL) Named without a submission number |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 4, 2022 | Class II | Z-0898-2022 | Material/Component Contamination | Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K2012860.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V.…Nurse Assist, LLC · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K171109 (Medxl, Inc., 2017) has gone furthest, with 6 descendants of its own.
How does its category compare?
All NGT devicesNGT Saline, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Excelsior Sterile Field Saline Flush Syringe(s) are intended for use in flushing IV catheters and IV tubing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082837: Sterile Field Saline Pre-Filled Syringe (S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082837
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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