510(k) · Cleared
ClearedNeutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation - Renal Division · FPA Set, Administration, Intravascular
Cleared on May 22, 2012 as substantially equivalent to K003225 (Baxter Healthcare Corp, 2000) and 2 other predicates after a 98-day review. Its family tree reaches back 4 generations to 1995. 28 later devices descend from it.
- Decided
- May 22, 2012
- Review
- 98 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K942988 (1995). 7 ancestors in all. 28 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 3 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 2 generations backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- 1 generation backK991653 Invision-Plus Injection Port Connector SystemRymed Technologies, Inc. · 1999 · Recalled
- This deviceK120443 Neutral Luer Activated Device and Extension Sets with Neutral Luer…Baxter Healthcare Corporation - Renal Division · 2012
- Descendant · cites it directly · 26 of its ownK132413 MZ1000Care Fusion · 2013
- Descendant · 2 generations on · 13 of its ownK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
- Descendant · 2 generations on · 6 of its ownK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
- Descendant · 3 generations on · 5 of its ownK183399 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 4 of its ownK162804 Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K132413MZ1000Care Fusion · 2013 · cites it directly26descendants
- K140831Maxzero Extension Set with Needless ConnectorCare Fusion · 2014 · 2 generations on13descendants
- K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company · 2017 · 2 generations on6descendants
- K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · 3 generations on5descendants
- K162804Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −3 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −2 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| −1 | K991653 | Invision-Plus Injection Port Connector System | Rymed Technologies, Inc. | 1999 | 4 |
| 0 (this device) | K120443 | Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated… | Baxter Healthcare Corporation - Renal Division | 2012 | — |
| +1 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| +2 | K140831 | Maxzero Extension Set with Needless Connector | Care Fusion | 2014 | — |
| +2 | K170336 | BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless… | Becton, Dickinson and Company | 2017 | — |
| +3 | K183399 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2019 | 3 |
| +3 | K162804 | Q2 Low Pressure Power Injection Extension Set | Quest Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 6 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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 |
|---|---|---|---|
| * | K003225 | Solution Administration Sets with Capless Luer Activated ValveSummary page 2…evices are cited in support of the substantial equivalence determination: * Baxter Healthcare Solution Administration Sets with Capped Luer Activated Valve, K003225 cleared on October 19, 2000 " Pressure Rated Extension Sets, K083472 cleared on November 18, 2008 9 InVision Plus Injec… | 2000 |
| * | K083472 | Medegen Pressure Rated Extension SetsSummary page 2…* Baxter Healthcare Solution Administration Sets with Capped Luer Activated Valve, K003225 cleared on October 19, 2000 " Pressure Rated Extension Sets, K083472 cleared on November 18, 2008 9 InVision Plus Injection Port Systems, K99 1653, cleared June 24, 1999 DESCRIPTION OF THE DEV… | 2008 |
| * | K991653 | Invision-Plus Injection Port Connector SystemSummary page 2…Valve, K003225 cleared on October 19, 2000 " Pressure Rated Extension Sets, K083472 cleared on November 18, 2008 9 InVision Plus Injection Port Systems, K99 1653, cleared June 24, 1999 DESCRIPTION OF THE DEVICE: The Neutral Luer Activated Device (LAD) and Extension Sets with Neutral Luer… | 1999 |
What descends from it? (28)
See all 282 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 17 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 6 of the 7 ancestors have a recall of any class.
- Of its descendants, K132413 (Care Fusion, 2013) has gone furthest, with 26 descendants of its own.
- 4 other devices also cite its predicate K003225.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The Baxter Neutral Luer Activated Device is intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use. This device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids. This device may be used with low pressure power injectors having a maximum pressure of 325 psi (2241 kPa) and a maximum flow rate of 10 mL/s.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120443 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120443: Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120443
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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