510(k) · Cleared
ClearedEasyPoint Blood Collection Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Retractable Technologies, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Apr 9, 2021 as substantially equivalent to K982541 (Becton Dickinson Vacutainer Systems, 1998) after a 235-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Apr 9, 2021
- Review
- 235 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972404 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK972404 Vacutainer Brand Safety Blood Collection Assembly (Multiple)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1997 · Recalled
- 1 generation backK982541 Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 &…Becton Dickinson Vacutainer Systems · 1998 · Recalled
- This deviceK202325 EasyPoint Blood Collection PlusRetractable Technologies, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972404 | Vacutainer Brand Safety Blood Collection Assembly (Multiple) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | 1 |
| −1 | K982541 | Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608 | Becton Dickinson Vacutainer Systems | 1998 | 1 |
| 0 (this device) | K202325 | EasyPoint Blood Collection Plus | Retractable Technologies, Inc. | 2021 | — |
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 |
|---|---|---|---|
| * | K982541 | Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608Summary page 4…ulatory Class: II Product Codes: JKA, FMI 510k Number: K202325 III. PREDICATE DEVICE K982541 - Vacutainer@ EclipseTm Blood Collection Needle IV. DEVICE DESCRIPTION The EasyPoint® Blood Collection Plus is a blo… | 1998 |
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 24 years and passes through 3 companies; a new generation was cleared every 22.4 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 7 other devices also cite its predicate K982541.
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. 2021, 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 EasyPoint@ Blood Collection Plus is intended for use with evacuated blood collection tubes for venous blood collection, while aiding in the prevention of needlestick injuries and contaminated needle exposure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202325: EasyPoint Blood Collection Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202325
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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