510(k) · Cleared
ClearedMonoject Luer Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sherwood Medical Co. · FMI Needle, Hypodermic, Single Lumen
Cleared on Sep 14, 1994 after a 196-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 58 devices in its family, counting itself, have a Class I recall. 57 later devices descend from it.
- Decided
- Sep 14, 1994
- Review
- 196 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 0
57 later devices descend from it, 1 citing it directly. 3 of the 58 devices in this family, counting this one, have a Class I recall.
- This deviceK940961 Monoject Luer AdapterSherwood Medical Co. · 1994
- Descendant · cites it directly · 56 of its ownK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- Descendant · 2 generations on · 49 of its ownK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
- Descendant · 3 generations on · 38 of its ownK023747 PhasealCarmel Pharma Ab. · 2002
- Descendant · 4 generations on · 37 of its ownK110023 Infusion Adapter C100Carmel Pharma Ab. · 2011
- Descendant · 2 generations on · 36 of its ownK092782 Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector…Carmel Pharma Ab. · 2009
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 57 · See all- K972527Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997 · cites it directly56descendants
- K980381Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration…Carmel Pharma Ab. · 1998 · 2 generations on49descendants
- K023747PhasealCarmel Pharma Ab. · 2002 · 3 generations on38descendants
- K110023Infusion Adapter C100Carmel Pharma Ab. · 2011 · 4 generations on37descendants
- K092782Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C…Carmel Pharma Ab. · 2009 · 2 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940961 | Monoject Luer Adapter | Sherwood Medical Co. | 1994 | — |
| +1 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| +2 | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional… | Carmel Pharma Ab. | 1998 | — |
| +3 | K023747 | Phaseal | Carmel Pharma Ab. | 2002 | — |
| +4 | K110023 | Infusion Adapter C100 | Carmel Pharma Ab. | 2011 | — |
| +2 | K092782 | Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock… | Carmel Pharma Ab. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 1 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 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 | 4 | 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.
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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 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? (57)
See all 571 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | 1997 | 56 |
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 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K170095Vial2Bag Direct ConnectMedimop Medical Project, Ltd. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K972527 (Quality System Consulting, 1997) has gone furthest, with 56 descendants of its own.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
https://510kreport.com/device/K940961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940961: Monoject Luer Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940961
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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