510(k) · Cleared
ClearedBevel Up Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nsp Tech Pte, Ltd. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Apr 21, 2020 as substantially equivalent to K122687 (Greiner Bio-One North America, Inc., 2013) after a 169-day review. Its family tree reaches back 4 generations to 1989. 1 later device descends from it.
- Decided
- Apr 21, 2020
- Review
- 169 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K895367 (1989). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK895367 Intravenous Extension SetMedical Product Specialists · 1989 · Recalled
- 3 generations backK072783 Saf-T Closed Blood Collection System with Saf-Holder Device, Model…Smiths Medical Asd, Inc. · 2007
- 2 generations backK081229 Saf-T Closed Blood Collection System with Saf-Holder Device, with…Smiths Medical Asd, Inc. · 2008
- 1 generation backK122687 Blood Culture HolderGreiner Bio-One North America, Inc. · 2013
- This deviceK193074 Bevel Up HolderNsp Tech Pte, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK232881 Winged Infusion Set, Safety Winged Infusion Set, Blood Collection…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232881Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K895367 | Intravenous Extension Set | Medical Product Specialists | 1989 | 6 |
| −3 | K072783 | Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200… | Smiths Medical Asd, Inc. | 2007 | — |
| −2 | K081229 | Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G… | Smiths Medical Asd, Inc. | 2008 | — |
| −1 | K122687 | Blood Culture Holder | Greiner Bio-One North America, Inc. | 2013 | — |
| 0 (this device) | K193074 | Bevel Up Holder | Nsp Tech Pte, Ltd. | 2020 | — |
| +1 | K232881 | Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood… | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
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 |
|---|---|---|---|
| K232881 | Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection… | 2023 | 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 31 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K232881 (Jiangsu Kangbao Medical Equipment Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122687.
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. 2020, 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 Bevel Up Holder is used for the collection of blood into blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. The device is to be used by trained healthcare professional only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193074: Bevel Up Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193074
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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