510(k) · Cleared
ClearedSamplok Luer Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Itl Corporation Pty, Ltd. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jul 2, 2002 as substantially equivalent to K000777 (Itl Corporation Pty, Ltd., 2000) and 1 other predicate after a 19-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it.
- Decided
- Jul 2, 2002
- Review
- 19 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K861152 (1986). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK861152 Exel Vacuum Blood Collecting SystemExel Intl. · 1986
- 1 generation backK992729 Nipro Luer AdaptorNipro Medical Corp. · 2000
- This deviceK021941 Samplok Luer KitItl Corporation Pty, Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK120490 Quick Sampler HolderNipro Medical Corporation · 2012
Most influential descendants
Showing 1 of 1 · See all- K120490Quick Sampler HolderNipro Medical Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861152 | Exel Vacuum Blood Collecting System | Exel Intl. | 1986 | — |
| −1 | K992729 | Nipro Luer Adaptor | Nipro Medical Corp. | 2000 | — |
| 0 (this device) | K021941 | Samplok Luer Kit | Itl Corporation Pty, Ltd. | 2002 | — |
| +1 | K120490 | Quick Sampler Holder | Nipro Medical Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 JKA? 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 JKA device
- #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 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 |
|---|---|---|---|
| * | K000777 | SamplokSummary page 1…ent Registration Number: 9033436 Class: I1 Product Code: JKA Legally Marketed Substantially Equivalent Devices: SampLok@Needle Holder (K000777) and Nipro Luer Adaptor (K992729) Description of Device: Luer Kit for use with blood collection systems for collecting… | 2000 |
| * | K992729 | Nipro Luer AdaptorSummary page 1…Class: I1 Product Code: JKA Legally Marketed Substantially Equivalent Devices: SampLok@Needle Holder (K000777) and Nipro Luer Adaptor (K992729) Description of Device: Luer Kit for use with blood collection systems for collecting blood samples Int… | 2000 |
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 |
|---|---|---|---|
| K120490 | Quick Sampler Holder | 2012 | 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 16 years and passes through 3 companies; a new generation was cleared every 13.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K120490 (Nipro Medical Corporation, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JKA devicesJKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JKA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JKA
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JKA
13in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKA
6,089in 2025
MAUDE reports naming product code JKA, 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 | 4 | 281 | 3 | 73 |
| 2008 | 2 | — | 3 | 78 |
| 2009 | 2 | — | 3 | 42 |
| 2010 | 4 | 28 | 4 | 37 |
| 2011 | 0 | — | 14 | 67 |
| 2012 | 1 | — | 2 | 54 |
| 2013 | 3 | 244 | 1 | 33 |
| 2014 | 1 | — | 1 | 68 |
| 2015 | 1 | — | 6 | 41 |
| 2016 | 4 | 116 | 1 | 65 |
| 2017 | 2 | — | 2 | 2,039 |
| 2018 | 1 | — | 2 | 9,731 |
| 2019 | 6 | 181 | 9 | 6,469 |
| 2020 | 6 | 181 | 0 | 3,774 |
| 2021 | 4 | 217 | 3 | 3,610 |
| 2022 | 9 | 164 | 2 | 3,375 |
| 2023 | 17 | 189 | 2 | 4,400 |
| 2024 | 6 | 240 | 0 | 4,609 |
| 2025 | 7 | 115 | 13 | 6,089 |
| 2026 | 8 | 250 | 1 | — |
What is it indicated for?
The ITL SampLok® Luer Kit is intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021941: Samplok Luer Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021941
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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