510(k) · Cleared
Recalled · Class II · 2019MaxZero Extension Sets with Needless Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion 303, Inc. · FPA Set, Administration, Intravascular
Cleared on Jul 19, 2017 as substantially equivalent to K140831 (Care Fusion, 2014) after a 20-day review. Its family tree reaches back 7 generations to 1995. It has been recalled 34 times.
- Decided
- Jul 19, 2017
- Review
- 20 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 34
- Predicates
- 1
Its longest line of descent runs back 7 generations to K942988 (1995). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 6 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 5 generations backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- 4 generations backK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
- 3 generations backK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
- 2 generations backK132413 MZ1000Care Fusion · 2013
- 1 generation backK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
- This deviceK171957 MaxZero Extension Sets with Needless ConnectorCarefusion 303, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −6 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −5 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| −4 | K021692 | CLC2000 Catheter Patency Device | Icu Medical, Inc. | 2003 | — |
| −3 | K100434 | Clave Neutron | Icu Medical, Inc. | 2010 | 3 |
| −2 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| −1 | K140831 | Maxzero Extension Set with Needless Connector | Care Fusion | 2014 | — |
| 0 (this device) | K171957 | MaxZero Extension Sets with Needless Connector | Carefusion 303, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K140831 | Maxzero Extension Set with Needless ConnectorSummary page 4…Trade Name: MaxZero™ Extension Sets with Needleless Connector Manufacturer: Carefusion, Inc. 510k Number: K140831 510K Clearance Date: April 15 2014 Reason for Submission The objective of this submission is to introduce new co… | 2014 |
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 |
|---|---|---|---|---|
| Apr 24, 2019 | Class II | Z-0082-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0083-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0096-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0099-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0105-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0075-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0076-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0078-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0080-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0084-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0089-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0090-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0093-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0094-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0098-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0103-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0106-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0077-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0088-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0097-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0079-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0081-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0100-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0101-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0102-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0085-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0107-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0086-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0087-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0091-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0092-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0095-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 24, 2019 | Class II | Z-0104-2020 | Under Investigation by firm | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
| Apr 10, 2019 | Class II | Z-0284-2020 | Under Investigation by firm | BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of fluid separating from the sealed surface of the MaxZero connector, following disconnection. |
The 5 latest of 34 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 10 of the 17 ancestors have a recall of any class.
- 5 other devices also cite its predicate K140831.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2007high 23 (2010) · low 4 (2018)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
2007high 340 (2023) · low 75 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
2007high 166 (2009) · low 1 (2021)2026
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
2007high 47,210 (2024) · low 1,499 (2007)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?
Pressure Rated: The MaxZero™ Extension Set with Needle-Free Connector(s) is for single use only. The MaxZero™ Extension Set with Needle-Free Connector(s) may be used for direct injection, intermittent infusion, continuous infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10mL per second.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171957: MaxZero Extension Sets with Needless Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171957
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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