510(k) · Cleared
ClearedPhaseal Protector P14, P21, P28 and P50
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 23, 2009 as substantially equivalent to K001368 (Carmel Pharma Ab., 2000) after a 14-day review. Its family tree reaches back 1 generation to 2000. 1 of the 38 devices in its family, counting itself, has a Class I recall. 36 later devices descend from it.
- Decided
- Mar 23, 2009
- Review
- 14 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001368 (2000). 36 later devices descend from it, 1 citing it directly. 1 of the 38 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK001368 Protector 21, Protector 50, Protector 14, Injector Luer Lock…Carmel Pharma Ab. · 2000 · Recalled
- This deviceK090634 Phaseal Protector P14, P21, P28 and P50Carmel Pharma Ab. · 2009
- 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)
- Descendant · 3 generations on · 9 of its ownK141448 Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015
Showing 5 of 36 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 36 · See all- 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
- K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001368 | Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter | Carmel Pharma Ab. | 2000 | 4 |
| 0 (this device) | K090634 | Phaseal Protector P14, P21, P28 and P50 | Carmel Pharma Ab. | 2009 | — |
| +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 |
| +3 | K141448 | Tevadaptor Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K001368 | Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion AdapterSummary page 1…fication Status: Class II per 21 CFR 880.5440 Product code: LHI 2. Equivalent devices Protector P14, P21 and P50 cleared in K001368 3. Description of the Device The single lumen docking station of the Protector is fitted to the drug vial for the p… | 2000 |
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120384 | Protector, Injector, Connector | 2012 | 35 |
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?
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. 2009, 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 indication for use is reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the reconstitution, administration and disposal process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090634 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090634: Phaseal Protector P14, P21, P28 and P50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090634
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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