510(k) · Cleared
ClearedPhaseal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carmel Pharma Ab. · LHI Set, I.V. Fluid Transfer
Cleared on Nov 15, 2002 as substantially equivalent to K980381 (Carmel Pharma Ab., 1998) and 1 other predicate after a 7-day review. Its family tree reaches back 3 generations to 1988. 1 of the 45 devices in its family, counting itself, has a Class I recall. 38 later devices descend from it.
- Decided
- Nov 15, 2002
- Review
- 7 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K883614 (1988). 6 ancestors in all. 38 later devices descend from it, 2 citing it directly. 1 of the 45 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 2 generations backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- 1 generation backK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
- This deviceK023747 PhasealCarmel Pharma Ab. · 2002
- Descendant · cites it directly · 37 of its ownK110023 Infusion Adapter C100Carmel Pharma Ab. · 2011
- Descendant · cites it directly · 35 of its ownK120384 Protector, Injector, ConnectorBd Medical-Medical Surgical Systems · 2012
- Descendant · 2 generations on · 34 of its ownK123213 BD Phaseal Closed System Transfer DeviceBecton, Dickinson & CO · 2013 · Recalled
- Descendant · 3 generations on · 19 of its ownK130197 BD Phaseal Closed System Transfer Device - P55Becton, Dickinson and Company · 2013 · Recalled
- Descendant · 3 generations on · 10 of its ownK131549 Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · Recalled (Class I)
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K131549 Chemolock, Chemolock Port3 generations on · 2013
Most influential descendants
Showing 5 of 38 · See all- K110023Infusion Adapter C100Carmel Pharma Ab. · 2011 · cites it directly37descendants
- K120384Protector, Injector, ConnectorBd Medical-Medical Surgical Systems · 2012 · cites it directly35descendants
- K123213BD Phaseal Closed System Transfer DeviceBecton, Dickinson & CO · 2013 · 2 generations on34descendants
- K130197BD Phaseal Closed System Transfer Device - P55Becton, Dickinson and Company · 2013 · 3 generations on19descendants
- K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −2 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| −1 | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional… | Carmel Pharma Ab. | 1998 | — |
| 0 (this device) | K023747 | Phaseal | Carmel Pharma Ab. | 2002 | — |
| +1 | K110023 | Infusion Adapter C100 | Carmel Pharma Ab. | 2011 | — |
| +1 | K120384 | Protector, Injector, Connector | Bd Medical-Medical Surgical Systems | 2012 | — |
| +2 | K123213 | BD Phaseal Closed System Transfer Device | Becton, Dickinson & CO | 2013 | 2 |
| +3 | K130197 | BD Phaseal Closed System Transfer Device - P55 | Becton, Dickinson and Company | 2013 | 1 |
| +3 | K131549 | Chemolock, Chemolock Port | Icu Medical, Inc. | 2013 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 1 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 8 | 0 |
| 2025 | 6 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration…Summary page 1…brane technique. Com parison of Predicate Devices/Equ ivalence The device is substantially equivalent to previously accepted PhaSeal devices included in 5 1O(k) Number K980381 and KOO1368. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 1998 |
| * | K001368 | Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter | 2000 |
What descends from it? (38)
See all 382 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K110023 (Carmel Pharma Ab., 2011) has gone furthest, with 37 descendants of its own.
- 6 other devices also cite its predicate K980381.
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 | — |
What is it indicated for?
The Infusion Adapter serves as a the connecting part between the IV bag and an external IV line (e.g. IV regulators). The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal double membrane technique.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023747 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023747: Phaseal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023747
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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