510(k) · Cleared
ClearedVACUETTE® QUICKSHIELD Complete (Plus)
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 Jul 19, 2024 as substantially equivalent to K200027 (Jiangsu Caina Medical Co.,Ltd, 2020) and 1 other predicate after a 214-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Jul 19, 2024
- Review
- 214 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K972404 (1997). 13 ancestors in all, the oldest K931367 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK972404 Vacutainer Brand Safety Blood Collection Assembly (Multiple)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1997 · Recalled
- 3 generations backK982541 Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 &…Becton Dickinson Vacutainer Systems · 1998 · Recalled
- 2 generations backK033478 Vacuette Quickshield Safety Tube HolderGreiner Bio-One Vacuette North America · 2003
- 1 generation backK072320 Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc. · 2007 · Recalled
- This deviceK233979 VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972404 | Vacutainer Brand Safety Blood Collection Assembly (Multiple) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | 1 |
| −3 | K982541 | Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608 | Becton Dickinson Vacutainer Systems | 1998 | 1 |
| −2 | K033478 | Vacuette Quickshield Safety Tube Holder | Greiner Bio-One Vacuette North America | 2003 | — |
| −1 | K072320 | Greiner Vacuette Quickshield Complete | Greiner Bio-One North America, Inc. | 2007 | 1 |
| 0 (this device) | K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without…Summary page 5…older, Luer Access Device-holder with Pre-attached Multiple Sample Adapter (K200027) Secondary predicate device: VACUETTE® QUICKSHIELD Complete (K072320) 4. DEVICE DESCRIPTION The sterile… | 2020 |
| * | K072320 | Greiner Vacuette Quickshield CompleteSummary page 5…attached Multiple Sample Adapter (K200027) Secondary predicate device: VACUETTE® QUICKSHIELD Complete (K072320) 4. DEVICE DESCRIPTION The sterile VACUETTE® QUICKSHIELD Complete is a single packed VACUETTE® QUICKSHIELD Safety Tube H… | 2007 |
| † | K973620 | Vacuette Multi-Sample Needle | 1997 |
| † | K061483 | Vacuette Visio Plus Blood Collection Needles | 2006 |
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 27 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 4 of the 13 ancestors have a recall of any class.
- 4 other devices also cite its predicate K200027.
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. 2024, 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 VACUETTE® QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. They are for single-use only and should be used by properly trained healthcare professionals only in accordance with…
Read the full statement (183 words)
The VACUETTE® QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. They are for single-use only and should be used by properly trained healthcare professionals only in accordance with these instructions.
The VACUETTE® QUICKSHIELD Complete PLUS is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. VACUETTE® VISIO PLUS Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.
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/K233979 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233979: VACUETTE® QUICKSHIELD Complete (Plus).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233979
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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