510(k) · Cleared
Recalled · 2007Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter
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 May 12, 2000 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 45 devices in its family, counting itself, have a Class I recall. 44 later devices descend from it. It has been recalled 4 times.
- Decided
- May 12, 2000
- Review
- 11 days
- Class
- Class II
- Product code
- LHI
- Recalls
- 4
- Predicates
- 0
44 later devices descend from it, 5 citing it directly. 2 of the 45 devices in this family, counting this one, have a Class I recall.
- This deviceK001368 Protector 21, Protector 50, Protector 14, Injector Luer Lock…Carmel Pharma Ab. · 2000
- 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 ownK092782 Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector…Carmel Pharma Ab. · 2009
- Descendant · cites it directly · 36 of its ownK090634 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
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 44 · See all- K023747PhasealCarmel Pharma Ab. · 2002 · cites it directly38descendants
- K110023Infusion Adapter C100Carmel Pharma Ab. · 2011 · 2 generations on37descendants
- K092782Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C…Carmel Pharma Ab. · 2009 · cites it directly36descendants
- K090634Phaseal Protector P14, P21, P28 and P50Carmel Pharma Ab. · 2009 · cites it directly36descendants
- K120384Protector, Injector, ConnectorBd Medical-Medical Surgical Systems · 2012 · cites it directly35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001368 | Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter | Carmel Pharma Ab. | 2000 | — |
| +1 | K023747 | Phaseal | Carmel Pharma Ab. | 2002 | — |
| +2 | K110023 | Infusion Adapter C100 | Carmel Pharma Ab. | 2011 | — |
| +1 | K092782 | Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock… | Carmel Pharma Ab. | 2009 | — |
| +1 | K090634 | Phaseal Protector P14, P21, P28 and P50 | Carmel Pharma Ab. | 2009 | — |
| +1 | K120384 | Protector, Injector, Connector | Bd Medical-Medical Surgical Systems | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 1 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 1 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (44)
See all 445 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2007 | Not classified | Z-1181-2007 | Other | Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. These rubber stoppers are made of… |
| Jun 26, 2007 | Not classified | Z-1180-2007 | Other | Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. These rubber stoppers are made of… |
| Jun 26, 2007 | Not classified | Z-1179-2007 | Other | Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. These rubber stoppers are made of… |
| Jun 26, 2007 | Not classified | Z-1178-2007 | Other | Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. These rubber stoppers are made of… |
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.
- K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- 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?
- Of its descendants, K023747 (Carmel Pharma Ab., 2002) has gone furthest, with 38 descendants 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/K001368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001368: Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001368
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026