510(k) · Cleared
Recalled · 2009Sterile Field Saline and Heparin Lock Flush Syringes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excelsior Medical Corp. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Dec 9, 2005 after a 32-day review. The FDA summary names its predicate without a number. 1 of the 11 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled once.
- Decided
- Dec 9, 2005
- Review
- 32 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 1
- Predicates
- 0
10 later devices descend from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- This deviceK053120 Sterile Field Saline and Heparin Lock Flush SyringesExcelsior Medical Corp. · 2005
- Descendant · cites it directly · 9 of its ownK082837 Sterile Field Saline Pre-Filled Syringe (S)Excelsior Medical Corp. · 2008 · Recalled
- Descendant · 2 generations on · 6 of its ownK171109 Praxiject 0.9% NaClMedxl, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK192414 Praxiject 0.9% NaClMedxl, Inc. · 2020
- Descendant · 4 generations on · 1 of its ownK231754 Praxiject™ 0.9% NaClMedxl, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK201286 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1…Nurse Assist, LLC · 2020 · Recalled (Class I)
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K201286 0.9% Sodium Chloride I.V. Flush Syringe for…3 generations on · 2020
Most influential descendants
Showing 5 of 10 · See all- K082837Sterile Field Saline Pre-Filled Syringe (S)Excelsior Medical Corp. · 2008 · cites it directly9descendants
- K171109Praxiject 0.9% NaClMedxl, Inc. · 2017 · 2 generations on6descendants
- K192414Praxiject 0.9% NaClMedxl, Inc. · 2020 · 3 generations on3descendants
- K231754Praxiject™ 0.9% NaClMedxl, Inc. · 2023 · 4 generations on1descendant
- K2012860.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9%…Nurse Assist, LLC · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053120 | Sterile Field Saline and Heparin Lock Flush Syringes | Excelsior Medical Corp. | 2005 | — |
| +1 | K082837 | Sterile Field Saline Pre-Filled Syringe (S) | Excelsior Medical Corp. | 2008 | 1 |
| +2 | K171109 | Praxiject 0.9% NaCl | Medxl, Inc. | 2017 | — |
| +3 | K192414 | Praxiject 0.9% NaCl | Medxl, Inc. | 2020 | — |
| +4 | K231754 | Praxiject™ 0.9% NaCl | Medxl, Inc. | 2023 | — |
| +3 | K201286 | 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch… | Nurse Assist, LLC | 2020 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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 |
|---|---|---|---|
| * | — | Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes Named without a submission number |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082837 | Sterile Field Saline Pre-Filled Syringe (S) | 2008 | 9 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 13, 2009 | Not classified | Z-0973-2009 | Packaging process control | Sterility Issue: There is the possibility that the affected lots have pouches that were not sealed properly and could potentially compromise the external sterility of the syringes. |
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.
- K2012860.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V.…Nurse Assist, LLC · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K082837 (Excelsior Medical Corp., 2008) has gone furthest, with 9 descendants of its own.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
Excelsior Sterile Field Saline Flush Syringes and Heparin Lock Flush Syringes are indicated for use in flushing IV catheters and IVtubing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053120: Sterile Field Saline and Heparin Lock Flush Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053120
Report an extraction error
Are you the manufacturer?
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