510(k) · Cleared
Recalled · Class II · 2017Improve Blood Collection Set and Improsafe Blood Collection Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Medical Technologies, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Aug 27, 2013 after a 244-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 27, 2013
- Review
- 244 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 3
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK123987 Improve Blood Collection Set and Improsafe Blood Collection SetInnovative Medical Technologies, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK202188 Safety Blood Collection Sets for Single UseAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK163093 Safety Blood Collection SetJiangsu Shenli Medical Production Co., Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K123987 | Improve Blood Collection Set and Improsafe Blood Collection Set | Innovative Medical Technologies, Inc. | 2013 | — |
| +1 | K202188 | Safety Blood Collection Sets for Single Use | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2021 | — |
| +1 | K163093 | Safety Blood Collection Set | Jiangsu Shenli Medical Production Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2017 | Class II | Z-2549-2018 | Under Investigation by firm | Leaks complaints. |
| Sep 22, 2017 | Class II | Z-1217-2019 | Nonconforming Material/Component | Complain due to the hub needle came out when the nurse draw the blood and removed the tube. |
| Oct 19, 2016 | Class II | Z-2790-2018 | Nonconforming Material/Component | Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K202188 (Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., 2021) 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. 2013, 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?
Improve Blood Collection Set and Improsafe Blood Collection Set are winged blood collection needles with flexible tubing and a female luer adapter intended for venipuncture to obtain blood samples from patients. Some reorder numbers are provided with a male luer adapter. The male luer adapter contains a non-patient needle end for puncturing the stopper of an evacuated blood collection tube. Those without a male luer adapter are provided with a protective…
Read the full statement (210 words)
Improve Blood Collection Set and Improsafe Blood Collection Set are winged blood collection needles with flexible tubing and a female luer adapter intended for venipuncture to obtain blood samples from patients. Some reorder numbers are provided with a male luer adapter. The male luer adapter contains a non-patient needle end for puncturing the stopper of an evacuated blood collection tube. Those without a male luer adapter are provided with a protective cap on the end of the female luer adapter.
The Improsafe Blood Collection Set is provided with an attached safety shield for covering the used needle prior to disposal. After withdrawal of the needle from the patient’s vein, the attached safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.
The Improve Blood Collection Set and Improsafe Blood Collection Set is also indicated for short-term (up to 2 hours) intravenous administration of fluids and may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. For devices that include the male luer adapter: after removing the attached male luer adapter from the blood collection set, connect the female luer adapter to a syringe or other compatible/appropriate device.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K123987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123987: Improve Blood Collection Set and Improsafe Blood Collection Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123987
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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