510(k) · Cleared
ClearedBD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jan 23, 2002 as substantially equivalent to K953120 (Vital Signs, Inc., 1995) and 2 other predicates after a 212-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Jan 23, 2002
- Review
- 212 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K952645 (1995). 4 ancestors in all, the oldest K953120 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK952645 Vital Signs Saline Vascular Access Flush DeviceVital Signs, Inc. · 1995
- 1 generation backK982558 BD Preefile Normal Saline Flush Syringe Flush SyringeBd/Preefil · 2000
- This deviceK011967 BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection…Bd · 2002
- Descendant · cites it directly · 1 of its ownK090680 Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush…Becton, Dickinson & CO · 2009
- Descendant · 2 generations on · 0 of its ownK163591 BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 2017
- Descendant · cites it directly · 0 of its ownK032417 Heparin Lock Flush SyringeAm2 Pat, Inc. · 2003 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K090680Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush SyringeBecton, Dickinson & CO · 2009 · cites it directly1descendant
- K163591BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 2017 · 2 generations on0descendants
- K032417Heparin Lock Flush SyringeAm2 Pat, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952645 | Vital Signs Saline Vascular Access Flush Device | Vital Signs, Inc. | 1995 | — |
| −1 | K982558 | BD Preefile Normal Saline Flush Syringe Flush Syringe | Bd/Preefil | 2000 | — |
| 0 (this device) | K011967 | BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe | Bd | 2002 | — |
| +1 | K090680 | Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe | Becton, Dickinson & CO | 2009 | — |
| +2 | K163591 | BD PosiFlush Heparin Lock Flush Syringe | Becton, Dickinson and Company | 2017 | — |
| +1 | K032417 | Heparin Lock Flush Syringe | Am2 Pat, Inc. | 2003 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 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.
Planning a device in FOZ? 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? (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 |
|---|---|---|---|
| * | K953120 | Vital Signs Heparin Vascular Access Flush DeviceSummary page 1…01) 847-4855 2 Device Name: Heparin Lock Flush Solution, USP BD Pre-Filled Heparin Lock Flush Syringe 3 Predicate Device(s): 3.1 Vital Signs Heparin Lock Flush Device K953120 3.2 BD Preefil™ Normal Saline Flush Syringe K982558 3.3 Baxter Heparin Lock Flush Syringe K003245 4 Product Description / Functi… | 1995 |
| * | K982558 | BD Preefile Normal Saline Flush Syringe Flush SyringeSummary page 1…tion, USP BD Pre-Filled Heparin Lock Flush Syringe 3 Predicate Device(s): 3.1 Vital Signs Heparin Lock Flush Device K953120 3.2 BD Preefil™ Normal Saline Flush Syringe K982558 3.3 Baxter Heparin Lock Flush Syringe K003245 4 Product Description / Function: Product sizes/reorder numbers: The following si… | 2000 |
| * | K003245 | Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush Syringe, 100 Usp Units/MLSummary page 1…inge 3 Predicate Device(s): 3.1 Vital Signs Heparin Lock Flush Device K953120 3.2 BD Preefil™ Normal Saline Flush Syringe K982558 3.3 Baxter Heparin Lock Flush Syringe K003245 4 Product Description / Function: Product sizes/reorder numbers: The following sizes/reorder numbers of the Heparin Lock Flush… | 2000 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K090680 (Becton, Dickinson & CO, 2009) has gone furthest, with 1 descendant 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?
The Heparin Lock Flush Solution, USP syringes are intended for use in maintaining
patency of vascular access devices (VAD’S).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011967 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011967: BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011967
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026