510(k) · Cleared
ClearedK-SHIELD Zen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sb-Kawasumi Laboratories, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Aug 29, 2022 as substantially equivalent to K011984 (Becton, Dickinson & CO, 2001) after a 164-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Aug 29, 2022
- Review
- 164 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970259 (1997). 6 ancestors in all, the oldest K921636 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK970259 E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
- 2 generations backK980414 Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
- 1 generation backK011984 BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO · 2001 · Recalled
- This deviceK220799 K-SHIELD ZenSb-Kawasumi Laboratories, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK230408 K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)Sb-Kawasumi Laboratories, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230408K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)Sb-Kawasumi Laboratories, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970259 | E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set | Becton Dickinson Vascular Access, Inc. | 1997 | — |
| −2 | K980414 | Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer… | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | 1 |
| −1 | K011984 | BD Vacutainer Push Button Blood Colection Set | Becton, Dickinson & CO | 2001 | 7 |
| 0 (this device) | K220799 | K-SHIELD Zen | Sb-Kawasumi Laboratories, Inc. | 2022 | — |
| +1 | K230408 | K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) | Sb-Kawasumi Laboratories, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011984 | BD Vacutainer Push Button Blood Colection SetSummary page 5…al 510(k) Premarket Notification K-SHIELD Zen III. PREDICATE DEVICE Predicate Device: • BD VACUTAINER Push Button Blood Collection Set (K011984) IV. DEVICE DESCRIPTION The K-SHIELD Zen is a winged blood collection set consisting with a cannula, flexible tube,… | 2001 |
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 |
|---|---|---|---|
| K230408 | K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) | 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 25 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K230408 (Sb-Kawasumi Laboratories, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K011984.
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?
K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-needle stick protector is an integral safety device intended to minimize accidental needlestick injuries.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220799 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220799: K-SHIELD Zen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220799
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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