510(k) · Cleared
ClearedProtector, Injector, Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Medical-Medical Surgical Systems · LHI Set, I.V. Fluid Transfer
Cleared on Sep 12, 2012 as substantially equivalent to K972527 (Quality System Consulting, 1997) and 7 other predicates after a 218-day review. Its family tree reaches back 5 generations to 1988. 1 of the 47 devices in its family, counting itself, has a Class I recall. 35 later devices descend from it.
- Decided
- Sep 12, 2012
- Review
- 218 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 5 generations to K883614 (1988). 11 ancestors in all. 35 later devices descend from it, 1 citing it directly. 1 of the 47 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 4 generations backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- 3 generations backK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
- 2 generations backK023747 PhasealCarmel Pharma Ab. · 2002
- 1 generation backK110023 Infusion Adapter C100Carmel Pharma Ab. · 2011
- This deviceK120384 Protector, Injector, ConnectorBd Medical-Medical Surgical Systems · 2012
- Descendant · cites it directly · 34 of its ownK123213 BD Phaseal Closed System Transfer DeviceBecton, Dickinson & CO · 2013 · Recalled
- Descendant · 2 generations on · 19 of its ownK130197 BD Phaseal Closed System Transfer Device - P55Becton, Dickinson and Company · 2013 · Recalled
- Descendant · 2 generations on · 10 of its ownK131549 Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 9 of its ownK141448 Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015
- Descendant · 3 generations on · 6 of its ownK132899 Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K131549 Chemolock, Chemolock Port2 generations on · 2013
Most influential descendants
Showing 5 of 35 · See all- K123213BD Phaseal Closed System Transfer DeviceBecton, Dickinson & CO · 2013 · cites it directly34descendants
- K130197BD Phaseal Closed System Transfer Device - P55Becton, Dickinson and Company · 2013 · 2 generations on19descendants
- K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · 2 generations on10descendants
- K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015 · 2 generations on9descendants
- K132899Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −4 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| −3 | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional… | Carmel Pharma Ab. | 1998 | — |
| −2 | K023747 | Phaseal | Carmel Pharma Ab. | 2002 | — |
| −1 | K110023 | Infusion Adapter C100 | Carmel Pharma Ab. | 2011 | — |
| 0 (this device) | K120384 | Protector, Injector, Connector | Bd Medical-Medical Surgical Systems | 2012 | — |
| +1 | K123213 | BD Phaseal Closed System Transfer Device | Becton, Dickinson & CO | 2013 | 2 |
| +2 | K130197 | BD Phaseal Closed System Transfer Device - P55 | Becton, Dickinson and Company | 2013 | 1 |
| +2 | K131549 | Chemolock, Chemolock Port | Icu Medical, Inc. | 2013 | Class I |
| +2 | K141448 | Tevadaptor Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2015 | — |
| +3 | K132899 | Equashield Closed System Drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 1 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 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? (8)
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…Telephone No: 201 847 5473 Name of Device: PhaSeal Closed System Drug Transfer Device Predicate Device(s): PhaSeal Protector: K972527, K001368, K090634 PhaSeal Injector: K972527, K980381, K001368,… | 1997 |
| * | K001368 | Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion AdapterSummary page 1…e No: 201 847 5473 Name of Device: PhaSeal Closed System Drug Transfer Device Predicate Device(s): PhaSeal Protector: K972527, K001368, K090634 PhaSeal Injector: K972527, K980381, K001368, K023747… | 2000 |
| * | K090634 | Phaseal Protector P14, P21, P28 and P50Summary page 1…201 847 5473 Name of Device: PhaSeal Closed System Drug Transfer Device Predicate Device(s): PhaSeal Protector: K972527, K001368, K090634 PhaSeal Injector: K972527, K980381, K001368, K023747, K060866… | 2009 |
| * | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration…Summary page 1…System Drug Transfer Device Predicate Device(s): PhaSeal Protector: K972527, K001368, K090634 PhaSeal Injector: K972527, K980381, K001368, K023747, K060866, K092782, KI 10023 PhaSeal Connect… | 1998 |
| * | K023747 | PhasealSummary page 1…PhaSeal Protector: K972527, K001368, K090634 PhaSeal Injector: K972527, K980381, K001368, K023747, K060866, K092782, KI 10023 PhaSeal Connector: K972527, K001368, K092782 Description of Device… | 2002 |
| * | K060866 | Phaseal - Closed System for the Preparation and Administration of Parenteral DrugsSummary page 1…PhaSeal Protector: K972527, K001368, K090634 PhaSeal Injector: K972527, K980381, K001368, K023747, K060866, K092782, KI 10023 PhaSeal Connector: K972527, K001368, K092782 Description of Device:… | 2006 |
| * | K092782 | Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C…Summary page 1…l Protector: K972527, K001368, K090634 PhaSeal Injector: K972527, K980381, K001368, K023747, K060866, K092782, KI 10023 PhaSeal Connector: K972527, K001368, K092782 Description of Device: The P… | 2009 |
| * | K110023 | Infusion Adapter C100 | 2011 |
What descends from it? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123213 | BD Phaseal Closed System Transfer Device | 2013 | 34 |
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 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K123213 (Becton, Dickinson & CO, 2013) has gone furthest, with 34 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. 2012, this device’s year, is highlighted.
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 PhaSeal system is a closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of, drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal Protector also prevents microbial ingress.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120384: Protector, Injector, Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120384
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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