510(k) · Cleared
ClearedInjector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C, Connector Luer Lock, Model C35,
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 Dec 7, 2009 as substantially equivalent to K972527 (Quality System Consulting, 1997) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 1988. 1 of the 42 devices in its family, counting itself, has a Class I recall. 36 later devices descend from it.
- Decided
- Dec 7, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K883614 (1988). 5 ancestors in all. 36 later devices descend from it, 1 citing it directly. 1 of the 42 devices in this family, counting this one, has 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 deviceK092782 Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector…Carmel 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 |
|---|---|---|---|---|---|
| −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) | K092782 | Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock… | 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 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic AgentsSummary page 1…Class II1 per 21 CFR 880.5440 Product code: LHII 2. Equivalent, devices Injector N430 and N431 and'Connector C40 cleared in.K972527 and KOOI368. 3. Description of the Device The, Injector and Conn~ector is a sterile device for single-use within the… | 1997 |
| * | K001368 | Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter | 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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K120384 (Bd Medical-Medical Surgical Systems, 2012) has gone furthest, with 35 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. 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?
Indications for use of the PhaSeal system and included components are reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drug 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/K092782 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092782: Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C, Connector Luer Lock, Model C35,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092782
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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