510(k) · Cleared
ClearedBlood Culture Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greiner Bio-One North America, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jan 10, 2013 as substantially equivalent to K081229 (Smiths Medical Asd, Inc., 2008) after a 128-day review. Its family tree reaches back 3 generations to 1989. 3 later devices descend from it.
- Decided
- Jan 10, 2013
- Review
- 128 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K895367 (1989). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK895367 Intravenous Extension SetMedical Product Specialists · 1989 · Recalled
- 2 generations backK072783 Saf-T Closed Blood Collection System with Saf-Holder Device, Model…Smiths Medical Asd, Inc. · 2007
- 1 generation backK081229 Saf-T Closed Blood Collection System with Saf-Holder Device, with…Smiths Medical Asd, Inc. · 2008
- This deviceK122687 Blood Culture HolderGreiner Bio-One North America, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK193074 Bevel Up HolderNsp Tech Pte, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK242320 BD Vacutainer® One Use HolderBecton, Dickinson and Company · 2024
- Descendant · 2 generations on · 0 of its ownK232881 Winged Infusion Set, Safety Winged Infusion Set, Blood Collection…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K193074Bevel Up HolderNsp Tech Pte, Ltd. · 2020 · cites it directly1descendant
- K242320BD Vacutainer® One Use HolderBecton, Dickinson and Company · 2024 · cites it directly0descendants
- K232881Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895367 | Intravenous Extension Set | Medical Product Specialists | 1989 | 6 |
| −2 | K072783 | Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200… | Smiths Medical Asd, Inc. | 2007 | — |
| −1 | K081229 | Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G… | Smiths Medical Asd, Inc. | 2008 | — |
| 0 (this device) | K122687 | Blood Culture Holder | Greiner Bio-One North America, Inc. | 2013 | — |
| +1 | K193074 | Bevel Up Holder | Nsp Tech Pte, Ltd. | 2020 | — |
| +1 | K242320 | BD Vacutainer® One Use Holder | Becton, Dickinson and Company | 2024 | — |
| +2 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K081229 | Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G, 25G Saf-T WingSummary page 1…11 PREDICATE DEVICE: Smiths Medical ASD Inc. Saf-T Closed Blood Collection System®o (K081229) DEVICE DESCRIPTION: INTENDED USE: Blood Culture Holder: The Blood Culture Holder is used to fill blood into… | 2008 |
What descends from it? (3)
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)
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 4.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K193074 (Nsp Tech Pte, Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K081229.
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?
The Blood Culture Holder is used to fill blood into blood culture bottles and tubes in routine venipuncture procedures. This device is to be used by property trained healthcare professionals only in accordance with these instructions.
The SAFETY Blood Collection Set and/or Blood Collection Set + Blood Culture Holder are used in routine venipuncture procedures. The winged needle of the SAFETY Blood Collection Set is designed with a safety shield, which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick Injury. The Blood Culture Holder is used to fill blood into blood culture bottles and tubes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122687 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122687: Blood Culture Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122687
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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