510(k) · Cleared
ClearedVacuette Quickshield Safety Tube Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greiner Bio-One Vacuette North America · FMI Needle, Hypodermic, Single Lumen
Cleared on Dec 29, 2003 as substantially equivalent to K982541 (Becton Dickinson Vacutainer Systems, 1998) after a 56-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it.
- Decided
- Dec 29, 2003
- Review
- 56 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972404 (1997). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK972404 Vacutainer Brand Safety Blood Collection Assembly (Multiple)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1997 · Recalled
- 1 generation backK982541 Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 &…Becton Dickinson Vacutainer Systems · 1998 · Recalled
- This deviceK033478 Vacuette Quickshield Safety Tube HolderGreiner Bio-One Vacuette North America · 2003
- Descendant · cites it directly · 2 of its ownK102774 Vacuette Quickshield with Snappy Tude HolderGreiner Bio-One North America, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK113505 Vacuette Quickshield with Snappy Tube HolderGreiner Bio-One North America, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK072320 Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK233979 VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK173279 RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube…Myco Medical Supplies, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K102774Vacuette Quickshield with Snappy Tude HolderGreiner Bio-One North America, Inc. · 2010 · cites it directly2descendants
- K113505Vacuette Quickshield with Snappy Tube HolderGreiner Bio-One North America, Inc. · 2012 · 2 generations on1descendant
- K072320Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc. · 2007 · cites it directly1descendant
- K233979VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc. · 2024 · 2 generations on0descendants
- K173279RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube HolderMyco Medical Supplies, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972404 | Vacutainer Brand Safety Blood Collection Assembly (Multiple) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | 1 |
| −1 | K982541 | Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608 | Becton Dickinson Vacutainer Systems | 1998 | 1 |
| 0 (this device) | K033478 | Vacuette Quickshield Safety Tube Holder | Greiner Bio-One Vacuette North America | 2003 | — |
| +1 | K102774 | Vacuette Quickshield with Snappy Tude Holder | Greiner Bio-One North America, Inc. | 2010 | 1 |
| +2 | K113505 | Vacuette Quickshield with Snappy Tube Holder | Greiner Bio-One North America, Inc. | 2012 | — |
| +1 | K072320 | Greiner Vacuette Quickshield Complete | Greiner Bio-One North America, Inc. | 2007 | 1 |
| +2 | K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. | 2024 | — |
| +3 | K173279 | RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder | Myco Medical Supplies, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 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 |
|---|---|---|---|
| * | K982541 | Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608Summary page 1…inson VACUTAINER® Brand ECLIPSE T M Blood Collection Needle (K982541) DEVICE DESCRIPTION: The VACUETTE ® QUICKSHIELD Safety Tube Holder is to be used together only with VACUETTE® Multi… | 1998 |
What descends from it? (5)
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 6 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K102774 (Greiner Bio-One North America, Inc., 2010) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K982541.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The VACUETTE® QUICKSHIELD Safety Tube Holder is to be used together only with VACUETTE® Multi-Sample Needles and 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033478 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033478: Vacuette Quickshield Safety Tube Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033478
Report an extraction error
Are you the manufacturer?
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