510(k) · Cleared
Recalled · Class II · 2015Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush Syringes for Sterile Delivery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Healthcare/Kendall · NGT Saline, Vascular Access Flush
Cleared on Apr 28, 2006 as substantially equivalent to K032438 (Tyco Healthcare, 2004) after a 77-day review. Its family tree reaches back 3 generations to 2000. 1 of the 5 devices in its family, counting itself, has a Class I recall. It has been recalled 11 times.
- Decided
- Apr 28, 2006
- Review
- 77 days
- Class
- Class II
- Product code
- NGT
- Recalls
- 11
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003245 (2000). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK003245 Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush…Baxter Healthcare Corp · 2000 · Recalled
- 2 generations backK013556 Monoject Prefill Heparin Lock Flush SyringeTyco Healthcare · 2001
- 1 generation backK032438 Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe…Tyco Healthcare · 2004 · Recalled (Class I)
- This deviceK060339 Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush…Tyco Healthcare/Kendall · 2006
Class I recalls in this family
- K032438 Modification to: Monojet Prefill 0.9% Sodium…direct predicate · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003245 | Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush Syringe, 100 Usp… | Baxter Healthcare Corp | 2000 | 2 |
| −2 | K013556 | Monoject Prefill Heparin Lock Flush Syringe | Tyco Healthcare | 2001 | — |
| −1 | K032438 | Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet… | Tyco Healthcare | 2004 | Class I |
| 0 (this device) | K060339 | Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush Syringes for… | Tyco Healthcare/Kendall | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 11.7 · 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 |
|---|---|---|---|
| * | K032438 | Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill…Summary page 1…equivalent in intended use, function and composition to the currently marketed Kendall Monoject PreFiII TMADVANCED 0M.9% Sodium Chloride Flush Syringes K032438. 4. Device Description The proposed device isan extension to the Kendall Monoject PreFiII TM ADVANCED TM… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2015 | Class II | Z-2527-2015 | Packaging process control | Sterility may be compromised |
| Aug 6, 2015 | Class II | Z-2530-2015 | Packaging process control | Sterility may be compromised |
| Aug 6, 2015 | Class II | Z-2526-2015 | Packaging process control | Sterility may be compromised |
| Aug 6, 2015 | Class II | Z-2533-2015 | Packaging process control | Sterility may be compromised |
| Aug 6, 2015 | Class II | Z-2531-2015 | Packaging process control | Sterility may be compromised |
| Aug 6, 2015 | Class II | Z-2534-2015 | Packaging process control | Sterility may be compromised |
| Aug 6, 2015 | Class II | Z-2529-2015 | Packaging process control | Sterility may be compromised |
| Aug 6, 2015 | Class II | Z-2535-2015 | Packaging process control | Sterility may be compromised |
| Aug 6, 2015 | Class II | Z-2525-2015 | Packaging process control | Sterility may be compromised |
| Aug 6, 2015 | Class II | Z-2528-2015 | Packaging process control | Sterility may be compromised |
| Aug 6, 2015 | Class II | Z-2536-2015 | Packaging process control | Sterility may be compromised |
The 5 latest of 11 recalls; the web page lists all.
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 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K032438.
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?
Kendall Monoject PreFill ADVANCED 0.9% Sodium Chloride Flush Syringes for Sterile Delivery is indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060339 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060339: Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush Syringes for Sterile Delivery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060339
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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