510(k) · Cleared
ClearedConceptoMed Luer-Jack Slip 10ml
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conceptomed AS · FMF Syringe, Piston
Cleared on Jan 11, 2017 as substantially equivalent to K110771 (Becton, Dickinson and Company, 2011) after a 169-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Jan 11, 2017
- Review
- 169 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980987 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK980987 Becton Dickinson SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
- 1 generation backK110771 BD Single Use, Hypodermic SyringeBecton, Dickinson and Company · 2011 · Recalled
- This deviceK162057 ConceptoMed Luer-Jack Slip 10mlConceptomed AS · 2017
- Descendant · cites it directly · 0 of its ownK171805 Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml…Conceptomed AS · 2017
Most influential descendants
Showing 1 of 1 · See all- K171805Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 mlConceptomed AS · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980987 | Becton Dickinson Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | 15 |
| −1 | K110771 | BD Single Use, Hypodermic Syringe | Becton, Dickinson and Company | 2011 | 10 |
| 0 (this device) | K162057 | ConceptoMed Luer-Jack Slip 10ml | Conceptomed AS | 2017 | — |
| +1 | K171805 | Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock… | Conceptomed AS | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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.
Planning a device in FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 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 |
|---|---|---|---|
| * | K110771 | BD Single Use, Hypodermic SyringeSummary page 4…General Hospital 2. Predicate Trade Name: BD Single use, Hypodermic Syringe Device 510(k) Reference: K110771 Common Name: BD Single use, Hypodermic Syringe Regulation Number:… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171805 | Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K171805 (Conceptomed AS, 2017) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K110771.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The ConceptoMed Luer-Jack device is a sterile syringe without needle intended for single use by health care professionals for general purpose aspiration or injection of fluids immediately after filling. The device is intended to be used only in combination with female 6% Luer slip connectors.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162057: ConceptoMed Luer-Jack Slip 10ml.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162057
Report an extraction error
Are you the manufacturer?
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