510(k) · Cleared
ClearedMonoject Prefill 0.9% Sodium Chloride Flush Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Kendall Company · NGT Saline, Vascular Access Flush
Cleared on Oct 15, 2001 after a 171-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Oct 15, 2001
- Review
- 171 days
- Class
- Class II
- Product code
- NGT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK011283 Monoject Prefill 0.9% Sodium Chloride Flush SyringeThe Kendall Company · 2001
- Descendant · cites it directly · 2 of its ownK032438 Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe…Tyco Healthcare · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK090882 Flush Syringe Filled with 0.9% Sodium ChlorideHospira, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 0 of its ownK060339 Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush…Tyco Healthcare/Kendall · 2006 · Recalled
Class I recalls in this family
- K032438 Modification to: Monojet Prefill 0.9% Sodium…cites it directly · 2004
Most influential descendants
Showing 3 of 3 · See all- K032438Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill…Tyco Healthcare · 2004 · cites it directly2descendants
- K090882Flush Syringe Filled with 0.9% Sodium ChlorideHospira, Inc. · 2010 · 2 generations on0descendants
- K060339Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush Syringes for Sterile DeliveryTyco Healthcare/Kendall · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011283 | Monoject Prefill 0.9% Sodium Chloride Flush Syringe | The Kendall Company | 2001 | — |
| +1 | K032438 | Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet… | Tyco Healthcare | 2004 | Class I |
| +2 | K090882 | Flush Syringe Filled with 0.9% Sodium Chloride | Hospira, Inc. | 2010 | 3 |
| +2 | K060339 | Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush Syringes for… | Tyco Healthcare/Kendall | 2006 | 11 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 1 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032438 | Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill… Class I | 2004 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K032438Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush SyringeTyco Healthcare · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K032438 (Tyco Healthcare, 2004) has gone furthest, with 2 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) | — |
https://510kreport.com/device/K011283 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011283: Monoject Prefill 0.9% Sodium Chloride Flush Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011283
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026