510(k) · Cleared
ClearedEclipse Blood Collection Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eclipse Medcorp, LLC · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Oct 26, 2022 as substantially equivalent to K200027 (Jiangsu Caina Medical Co.,Ltd, 2020) after a 337-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Oct 26, 2022
- Review
- 337 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K931367 (1993). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 3 generations backK983490 Terumo Venoject,Luer AdapterTerumo Corp. · 1998
- 2 generations backK991088 Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets…Becton Dickinson Vacutainer Systems · 1999 · Recalled
- 1 generation backK200027 Blood Collection Needle with/without Holder, Safety Blood Collection…Jiangsu Caina Medical Co.,Ltd · 2020
- This deviceK213690 Eclipse Blood Collection SetEclipse Medcorp, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −3 | K983490 | Terumo Venoject,Luer Adapter | Terumo Corp. | 1998 | — |
| −2 | K991088 | Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and… | Becton Dickinson Vacutainer Systems | 1999 | 4 |
| −1 | K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle… | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| 0 (this device) | K213690 | Eclipse Blood Collection Set | Eclipse Medcorp, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without…Summary page 4…, Tubes Regulation Name: Blood specimen collection device Regulation Number: 21 CFR 862.1675 (Product Code: JKA) Predicate Device: K200027 Blood Collection Needle Reference Device: K151991 Safelock Disposable Blood Collection Set… | 2020 |
| † | K151991 | Safelock Disposable Blood Collection Set, Disposable Blood Collection Set | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 4 other devices also cite its predicate K200027.
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. 2022, this device’s year, is highlighted.
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 Eclipse Blood Collection Set with holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213690 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213690: Eclipse Blood Collection Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213690
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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