510(k) · Cleared
Recalled · Class I · 2021Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Healthcare · NGT Saline, Vascular Access Flush
Cleared on Jun 30, 2004 as substantially equivalent to K011283 (The Kendall Company, 2001) and 1 other predicate after a 328-day review. Its family tree reaches back 2 generations to 2000. 1 of the 6 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 26 times, including 4 Class I recalls.
- Decided
- Jun 30, 2004
- Review
- 328 days
- Class
- Class II
- Product code
- NGT
- Recalls
- 26 (4 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003245 (2000). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK003245 Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush…Baxter Healthcare Corp · 2000 · Recalled
- 1 generation backK013556 Monoject Prefill Heparin Lock Flush SyringeTyco Healthcare · 2001
- This deviceK032438 Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe…Tyco Healthcare · 2004
- Descendant · cites it directly · 0 of its ownK090882 Flush Syringe Filled with 0.9% Sodium ChlorideHospira, Inc. · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK060339 Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush…Tyco Healthcare/Kendall · 2006 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003245 | Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush Syringe, 100 Usp… | Baxter Healthcare Corp | 2000 | 2 |
| −1 | K013556 | Monoject Prefill Heparin Lock Flush Syringe | Tyco Healthcare | 2001 | — |
| 0 (this device) | K032438 | Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet… | Tyco Healthcare | 2004 | — |
| +1 | K090882 | Flush Syringe Filled with 0.9% Sodium Chloride | Hospira, Inc. | 2010 | 3 |
| +1 | K060339 | Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush Syringes for… | Tyco Healthcare/Kendall | 2006 | 11 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K011283 | Monoject Prefill 0.9% Sodium Chloride Flush SyringeSummary page 1…valent in intended use, function and composition to the currently marketed Monoject PreFill Sodium Chloride and Heparin Lock Flush Syringes, 510(k) numbers K011283 and K013556. 4. Device Description The proposed device is a sterile, single use, standard piston syringe of va… | 2001 |
| * | K013556 | Monoject Prefill Heparin Lock Flush SyringeSummary page 1…tended use, function and composition to the currently marketed Monoject PreFill Sodium Chloride and Heparin Lock Flush Syringes, 510(k) numbers K011283 and K013556. 4. Device Description The proposed device is a sterile, single use, standard piston syringe of various sizes… | 2001 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Aug 19, 2021 | Class I | Z-0119-2022 | Device Design | Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduce air back into the syringe. |
| Aug 4, 2021 | Class I | Z-2284-2021 | Device Design | Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. |
| Aug 4, 2021 | Class I | Z-2286-2021 | Device Design | Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. |
| Aug 4, 2021 | Class I | Z-2285-2021 | Device Design | Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. |
| Aug 16, 2013 | Class II | Z-2178-2013 | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin |
| Aug 16, 2013 | Class II | Z-2185-2013 | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin |
| Aug 16, 2013 | Class II | Z-2184-2013 | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin |
| Aug 16, 2013 | Class II | Z-2183-2013 | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin |
| Aug 16, 2013 | Class II | Z-2182-2013 | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin |
| Aug 16, 2013 | Class II | Z-2186-2013 | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin |
| Aug 16, 2013 | Class II | Z-2180-2013 | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin |
| Aug 16, 2013 | Class II | Z-2179-2013 | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin |
| Aug 16, 2013 | Class II | Z-2181-2013 | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin |
| Nov 15, 2010 | Not classified | Z-0564-2011 | Material/Component Contamination | The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. |
| Nov 15, 2010 | Not classified | Z-0566-2011 | Material/Component Contamination | The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. |
| Nov 15, 2010 | Not classified | Z-0567-2011 | Material/Component Contamination | The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. |
| Nov 15, 2010 | Not classified | Z-0568-2011 | Material/Component Contamination | The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. |
| Nov 15, 2010 | Not classified | Z-0565-2011 | Material/Component Contamination | The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. |
| Nov 15, 2010 | Not classified | Z-0569-2011 | Material/Component Contamination | The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. |
| Mar 28, 2008 | Not classified | Z-1595-2008 | Material/Component Contamination | Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant |
| Mar 28, 2008 | Not classified | Z-1602-2008 | Material/Component Contamination | Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant |
| Mar 28, 2008 | Not classified | Z-1600-2008 | Material/Component Contamination | Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant |
| Mar 28, 2008 | Not classified | Z-1598-2008 | Material/Component Contamination | Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant |
| Mar 28, 2008 | Not classified | Z-1597-2008 | Material/Component Contamination | Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant Tyco Healthcare, Mansfield, MA 02048 |
| Mar 28, 2008 | Not classified | Z-1599-2008 | Material/Component Contamination | Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant |
| Mar 28, 2008 | Not classified | Z-1596-2008 | Material/Component Contamination | Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant |
The 5 latest of 26 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K090882 (Hospira, Inc., 2010) has gone furthest, with 0 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.
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 0.9% Sodium Chloride Flush Syringe is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
The Heparin Lock Flush Syringe, 10 and 100 units/ml is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032438: Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032438
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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