510(k) · Cleared
ClearedNeedleless Transfer Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medimop Medical Projects, Ltd. · LHI Set, I.V. Fluid Transfer
Cleared on Jul 11, 2000 after a 25-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jul 11, 2000
- Review
- 25 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK001831 Needleless Transfer DeviceMedimop Medical Projects, Ltd. · 2000
- Descendant · cites it directly · 1 of its ownK042410 Baxject IIBaxter Healthcare Corp · 2004
- Descendant · cites it directly · 1 of its ownK020666 Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter Healthcare Corp · 2002 · Recalled
- Descendant · cites it directly · 0 of its ownK092318 Baxject II HI-Flow Needleless Transfer DeviceBaxter Healthcare Corporation · 2009
- Descendant · 2 generations on · 0 of its ownK071126 Cryoseal FS Applicator SystemThermogenesis Corp. · 2007
Most influential descendants
Showing 4 of 4 · See all- K042410Baxject IIBaxter Healthcare Corp · 2004 · cites it directly1descendant
- K020666Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter Healthcare Corp · 2002 · cites it directly1descendant
- K092318Baxject II HI-Flow Needleless Transfer DeviceBaxter Healthcare Corporation · 2009 · cites it directly0descendants
- K071126Cryoseal FS Applicator SystemThermogenesis Corp. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001831 | Needleless Transfer Device | Medimop Medical Projects, Ltd. | 2000 | — |
| +1 | K042410 | Baxject II | Baxter Healthcare Corp | 2004 | — |
| +1 | K020666 | Duploject Easy-Prep System 1ML, 2ML, 5ML | Baxter Healthcare Corp | 2002 | 1 |
| +1 | K092318 | Baxject II HI-Flow Needleless Transfer Device | Baxter Healthcare Corporation | 2009 | — |
| +2 | K071126 | Cryoseal FS Applicator System | Thermogenesis Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LHI? 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 LHI device
- #1 K252987 ADRx™ Admixture Devicescore 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
3 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?
- Of its descendants, K042410 (Baxter Healthcare Corp, 2004) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LHI devicesLHI Set, I.V. Fluid Transfer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHI
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHI
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHI
1in 2024
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · LHI
1,334in 2025
MAUDE reports naming product code LHI, 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 | 3 | 89 | 1 | 18 |
| 2008 | 4 | 154 | 3 | 27 |
| 2009 | 8 | 95 | 1 | 37 |
| 2010 | 5 | 139 | 3 | 49 |
| 2011 | 3 | 99 | 12 | 155 |
| 2012 | 5 | 127 | 0 | 529 |
| 2013 | 4 | 102 | 3 | 154 |
| 2014 | 6 | 63 | 0 | 155 |
| 2015 | 3 | 99 | 0 | 128 |
| 2016 | 3 | 159 | 1 (1) | 219 |
| 2017 | 5 | 56 | 1 | 536 |
| 2018 | 1 | — | 3 (3) | 1,499 |
| 2019 | 4 | 247 | 1 | 1,634 |
| 2020 | 3 | 189 | 0 | 1,171 |
| 2021 | 3 | 396 | 0 | 933 |
| 2022 | 6 | 278 | 2 | 1,834 |
| 2023 | 5 | 90 | 2 (2) | 1,047 |
| 2024 | 9 | 166 | 1 | 1,270 |
| 2025 | 6 | 196 | 0 | 1,334 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K001831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001831: Needleless Transfer Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001831
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026