510(k) · Cleared
ClearedPhaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro
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 Mar 3, 1998 as substantially equivalent to K972527 (Quality System Consulting, 1997) after a 29-day review. Its family tree reaches back 2 generations to 1988. 3 of the 54 devices in its family, counting itself, have a Class I recall. 49 later devices descend from it.
- Decided
- Mar 3, 1998
- Review
- 29 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K883614 (1988). 4 ancestors in all. 49 later devices descend from it, 7 citing it directly. 3 of the 54 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 1 generation backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- This deviceK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
- Descendant · cites it directly · 38 of its ownK023747 PhasealCarmel Pharma Ab. · 2002
- Descendant · 2 generations on · 37 of its ownK110023 Infusion Adapter C100Carmel Pharma Ab. · 2011
- Descendant · cites it directly · 36 of its ownK060866 Phaseal - Closed System for the Preparation and Administration of…Carmel Pharma Ab. · 2006
- 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
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 49 · See all- K023747PhasealCarmel Pharma Ab. · 2002 · cites it directly38descendants
- K110023Infusion Adapter C100Carmel Pharma Ab. · 2011 · 2 generations on37descendants
- K060866Phaseal - Closed System for the Preparation and Administration of Parenteral DrugsCarmel Pharma Ab. · 2006 · cites it directly36descendants
- K120384Protector, Injector, ConnectorBd Medical-Medical Surgical Systems · 2012 · cites it directly35descendants
- K123213BD Phaseal Closed System Transfer DeviceBecton, Dickinson & CO · 2013 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −1 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| 0 (this device) | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional… | Carmel Pharma Ab. | 1998 | — |
| +1 | K023747 | Phaseal | Carmel Pharma Ab. | 2002 | — |
| +2 | K110023 | Infusion Adapter C100 | Carmel Pharma Ab. | 2011 | — |
| +1 | K060866 | Phaseal - Closed System for the Preparation and Administration of Parenteral… | Carmel Pharma Ab. | 2006 | — |
| +1 | K120384 | Protector, Injector, Connector | Bd Medical-Medical Surgical Systems | 2012 | — |
| +2 | K123213 | BD Phaseal Closed System Transfer Device | Becton, Dickinson & CO | 2013 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 1 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 1 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2017 | 4 | 1 |
| 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.
3 devices in this family have 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? (7)
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 |
|---|---|---|---|
| * | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic AgentsSummary page 1…Predicate Devices e Codan Medlon, IV Administration Set - Catalog Rev 3/1/93 B&P, preamendment device e Carmel Pharma ab, PhaSeal, a closed system for parenteral drugs, K972527 Product Description, Function, Safety and Efficacy PhaSeal is a closed system for preparation and administration of parenteral… | 1997 |
| * | — | Codan Medlon, IV Administration Set - Catalog Rev 3/1/93 B&P Named without a submission number | |
| * | — | Codan Medlon Inc. Vented Set (C 302 and C430) Named without a submission number | |
| * | — | Carmel Pharma ab, Infusion Set Named without a submission number | |
| * | — | Codan Medlon Inc. (BC 103) Special Accessories Luer Lock Plug Named without a submission number | |
| * | — | Carmel Pharma ab Connector Named without a submission number | |
| * | — | Codan Medloc Inc. Vented Set (BC 589) Named without a submission number |
What descends from it? (49)
See all 497 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023747 | Phaseal | 2002 | 38 |
| K060866 | Phaseal - Closed System for the Preparation and Administration of Parenteral Drugs | 2006 | 36 |
| K120384 | Protector, Injector, Connector | 2012 | 35 |
| K051669 | Tevadaptor Closed Drug Reconstitution and Transfer System | 2005 | 13 |
| K071741 | Tevadaptor, Closed Drug Reconstitution and Transfer System | 2007 | 11 |
| K072759 | VIAL2BAG Class I | 2007 | 2 |
| K132011 | Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer Set | 2014 | 0 |
Has anything in its family been recalled? (3 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.
- K072759VIAL2BAGMedimop Medical Projects, Ltd. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K170095Vial2Bag Direct ConnectMedimop Medical Project, Ltd. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K023747 (Carmel Pharma Ab., 2002) has gone furthest, with 38 descendants of its own.
- 4 other devices also cite its predicate K972527.
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?
PhaSeal Infusion Adapter - Intravascular Administration Set The Infusion Adapter serves as the connecting part between the IV bag and an external IV line. (Example IV regulators.) The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed double membrane technique. PhaSeal Protection Cap — Special accessories The Protection Cap is intended to be used as a mechanical cover for the…
Read the full statement (227 words)
PhaSeal Infusion Adapter - Intravascular Administration Set
The Infusion Adapter serves as the connecting part between the IV bag and an external IV line. (Example IV regulators.) The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed double membrane technique.
PhaSeal Protection Cap — Special accessories
The Protection Cap is intended to be used as a mechanical cover for the membrane in the bayonet fitting of PhaSeal devices The Protection Cap mates with the other PhaSeal components equipped with the bayonet fitting. One end of the Protection Cap has a male bayonet fitting and in the other a female bayonet fitting.
PhaSeal Secondary Set — Intravascular Administration Set
The Secondary Set is a non-vented infusion set used when drug is-handled as an admixtute and is administered via Intravenous infusion. The Secondary Set has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal technique.
PhaSeal Extension Set - Intravascular Administration Set
The Extension Set serves as the port for bolus injection with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Extension Set has a built in Connector which makes it possible inject drugs into the IV line of the patient using the sealed double membrane technique.
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/K980381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980381: Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980381
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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