510(k) · Cleared
ClearedPraxiject 0.9% NaCl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medxl, Inc. · NGT Saline, Vascular Access Flush
Cleared on Feb 13, 2020 as substantially equivalent to K171109 (Medxl, Inc., 2017) after a 162-day review. Its family tree reaches back 3 generations to 2005. 3 later devices descend from it.
- Decided
- Feb 13, 2020
- Review
- 162 days
- Class
- Class II
- Product code
- NGT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K053120 (2005). 3 later devices descend from it, 2 citing it directly.
- 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 deviceK192414 Praxiject 0.9% NaClMedxl, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK231754 Praxiject™ 0.9% NaClMedxl, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK233623 Praxiject™ SP 0.9% NaClMedxl, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK214080 PentaflushPentaferte Italia S.R.L. · 2022
Most influential descendants
Showing 3 of 3 · See allView 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) | K192414 | Praxiject 0.9% NaCl | Medxl, Inc. | 2020 | — |
| +1 | K231754 | Praxiject™ 0.9% NaCl | Medxl, Inc. | 2023 | — |
| +2 | K233623 | Praxiject™ SP 0.9% NaCl | Medxl, Inc. | 2024 | — |
| +1 | K214080 | Pentaflush | Pentaferte Italia S.R.L. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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.
Planning a device in NGT? 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…ala Premanathan, Regulatory Affairs Associate Predicate Device Device Trade Name: Praxiject™ 0.9% NaCl 510(k) Number: K171109 Classification: Class II, 21 CFR §880.5200, Saline, Vascular Access Flush Product Code:… | 2017 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 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, K231754 (Medxl, Inc., 2023) has gone furthest, with 1 descendant 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?
The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing vascular access devices. May be placed on a sterile field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192414: Praxiject 0.9% NaCl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192414
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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