510(k) · Cleared
Recalled · 2010Nima Needleless Injectionsite Master Adapter with Posiflow Positive Displacement Feature, and I.V. Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Critical Device Corp. · FPA Set, Administration, Intravascular
Cleared on Apr 14, 1997 after a 126-day review. The FDA summary names its predicate without a number. It has been recalled 8 times.
- Decided
- Apr 14, 1997
- Review
- 126 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 8
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | NIMA™ Needleless Injectionsite Master Adapter with PosiFlow™ Positive Displacement… Named without a submission number |
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 |
|---|---|---|---|---|
| Sep 9, 2010 | Not classified | Z-0155-2011 | Package design/selection | During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch. |
| Sep 9, 2010 | Not classified | Z-0154-2011 | Package design/selection | During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch. |
| Sep 9, 2010 | Not classified | Z-0156-2011 | Package design/selection | During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch. |
| Sep 9, 2010 | Not classified | Z-0157-2011 | Package design/selection | During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch. |
| Mar 3, 2005 | Not classified | Z-0853-05 | Other | Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction. |
| Mar 3, 2005 | Not classified | Z-0854-05 | Other | Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction. |
| Jan 20, 2005 | Not classified | Z-0693-05 | Other | Product older than three years may not operate as intended. |
| Jan 20, 2005 | Not classified | Z-0694-05 | Other | Product older than three years may not operate as intended. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For use as a needleless alternative to IV set injection ports. The NIMA™ adapter will replace the conventional Y-site on a primary IV line as a continuous or intermittent connection.
For use as part of a program to reduce needle stick injuries and the associated transmission of blood borne pathogens such as HIV and HBV.
For use as a replacement to the injection cap (heparin cap) on an I.V. catheter for intermittent injections.
For use for injection, as a gravity flow connector, and as an access port for withdrawal of fluids.
For use with standard luer taper connections.
For single patient use.
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/K964918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964918: Nima Needleless Injectionsite Master Adapter with Posiflow Positive Displacement Feature, and I.V. Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964918
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026