510(k) · Cleared
Recalled · Class II · 2012Flush Syringe Filled with 0.9% Sodium Chloride
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · NGT Saline, Vascular Access Flush
Cleared on Apr 23, 2010 as substantially equivalent to K001616 (Abbott Laboratories, 2000) and 2 other predicates after a 388-day review. Its family tree reaches back 3 generations to 2000. 1 of the 7 devices in its family, counting itself, has a Class I recall. It has been recalled 3 times.
- Decided
- Apr 23, 2010
- Review
- 388 days
- Class
- Class II
- Product code
- NGT
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 3 generations to K003245 (2000). 6 ancestors in all, the oldest K953805 (1996). No later device cites it as a predicate yet. 1 of the 7 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 deviceK090882 Flush Syringe Filled with 0.9% Sodium ChlorideHospira, Inc. · 2010
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) | K090882 | Flush Syringe Filled with 0.9% Sodium Chloride | Hospira, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 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 11.6 · 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? (3)
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 |
|---|---|---|---|
| * | K001616 | Modification to Syringe Prefilled with 0.9% Sodium ChlorideSummary page 1…me 510(k) Number Modification to Syringe Pre- filled with 0.9% Sodium K001616 Chloride Syringe Pre-filled with 0.9% K953805… | 2000 |
| * | K953805 | 0.9% Sodium Chloride Diluent in Plastic SyringeSummary page 1…filled with 0.9% Sodium K001616 Chloride Syringe Pre-filled with 0.9% K953805 Sodium Chloride Modification to Monoject… | 1996 |
| * | K032438 | Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill…Summary page 1…Sodium Chloride Modification to Monoject Pre-Fill 0.9% Sodium K032438 Chloride 5.6 Proposed Device Description: The proposed Flush Syringe pre-filled… | 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 |
|---|---|---|---|---|
| Sep 14, 2012 | Class II | Z-0663-2013 | Under Investigation by firm | Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The particular… |
| Nov 18, 2011 | Not classified | Z-0596-2012 | Material/Component Contamination | There is particulate matter in the fluid pathway, which has been identified as the same material as the rubber tip of the syringe plunger. |
| Sep 2, 2010 | Not classified | Z-0035-2011 | Device Design | There is the potential for a dimensional issue in 6 ml syringe products, codes E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, S5, to cause leakage and.or loss of sterility |
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 10 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All NGT devicesNGT Saline, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
For the flushing and assessing the. patency of indwelling catheters and venipuncture devices which are designed for intermittent injection therapy, blood sampling, or fluid and nutritional therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090882: Flush Syringe Filled with 0.9% Sodium Chloride.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090882
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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