510(k) · Cleared
Recalled · Class II · 2020Neutral Luer Activated Device (One-Link Needle-Free IV Connector) and Extension Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FPA Set, Administration, Intravascular
Cleared on Oct 8, 2013 as substantially equivalent to K120443 (Baxter Healthcare Corporation - Renal Division, 2012) after a 35-day review. Its family tree reaches back 5 generations to 1995. It has been recalled 2 times.
- Decided
- Oct 8, 2013
- Review
- 35 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K942988 (1995). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 4 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 3 generations backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- 2 generations backK991653 Invision-Plus Injection Port Connector SystemRymed Technologies, Inc. · 1999 · Recalled
- 1 generation backK120443 Neutral Luer Activated Device and Extension Sets with Neutral Luer…Baxter Healthcare Corporation - Renal Division · 2012
- This deviceK132734 Neutral Luer Activated Device (One-Link Needle-Free IV Connector)…Baxter Healthcare Corp · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −4 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −3 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| −2 | K991653 | Invision-Plus Injection Port Connector System | Rymed Technologies, Inc. | 1999 | 4 |
| −1 | K120443 | Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated… | Baxter Healthcare Corporation - Renal Division | 2012 | — |
| 0 (this device) | K132734 | Neutral Luer Activated Device (One-Link Needle-Free IV Connector) and… | Baxter Healthcare Corp | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 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 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? (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 |
|---|---|---|---|
| * | K120443 | Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated DeviceSummary page 2…e DeieCompany 5 10(k) date Neutral Luer Activated Device and Baxter H-ealthcare K120443 May 22. 2Q12 Extension Sets with Neutral Luer Activated Device DESCRIPTION OF THE DEVICE: The proposed device… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2020 | Class II | Z-1102-2021 | Process design | There were customer reports of separation between the tubing and Male Luer Lock Adaptor. |
| May 21, 2015 | Class II | Z-0132-2016 | Packaging | Potential for a leak at the tubing to luer bond. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K120443.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132734: Neutral Luer Activated Device (One-Link Needle-Free IV Connector) and Extension Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132734
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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