510(k) · Cleared
ClearedTevadaptor; Connecting Set W/ Ultrasite Injection Site, Spike Port Adaptor Set W/ Ultrasite Injection Site
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teva Medical Ltd., Migada Plant · FPA Set, Administration, Intravascular
Cleared on Jun 12, 2014 as substantially equivalent to K121269 (Migada Plant, 2013) after a 24-day review. Its family tree reaches back 1 generation to 2013.
- Decided
- Jun 12, 2014
- Review
- 24 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K121269 (2013). No later device cites it as a predicate yet.
- Root · 1 generation backK121269 TBAMigada Plant · 2013
- This deviceK141306 Tevadaptor; Connecting Set W/ Ultrasite Injection Site, Spike Port…Teva Medical Ltd., Migada Plant · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K121269 | TBA | Migada Plant | 2013 | — |
| 0 (this device) | K141306 | Tevadaptor; Connecting Set W/ Ultrasite Injection Site, Spike Port Adaptor Set… | Teva Medical Ltd., Migada Plant | 2014 | — |
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 |
|---|---|---|---|
| * | K121269 | TBASummary page 2…d Luer connection. The purpose of this Special 510(k) isto add the following two new designs of IVAdministration Sets to the one already cleared for sale in theUS under K121269: " TEVADAPTOR Connecting Set with ULTRASITE Injection Site * TEVADAPTOR Spike Port Adaptor with ULTRASITE Injection… | 2013 |
| † | K071741 | Tevadaptor, Closed Drug Reconstitution and Transfer System | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K121269.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 I.V. Administration Set is a single use, sterile I.V. set for administration of drugs and/or fluids from a container to a patient vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141306: Tevadaptor; Connecting Set W/ Ultrasite Injection Site, Spike Port Adaptor Set W/ Ultrasite Injection Site.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141306
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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