510(k) · Cleared
ClearedVacuette Quickshield with Snappy Tube Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greiner Bio-One North America, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Feb 17, 2012 as substantially equivalent to K102774 (Greiner Bio-One North America, Inc., 2010) after an 81-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.
- Decided
- Feb 17, 2012
- Review
- 81 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K972404 (1997). 1 later device descends from it, 1 citing it directly.
- 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 backK102774 Vacuette Quickshield with Snappy Tude HolderGreiner Bio-One North America, Inc. · 2010 · Recalled
- This deviceK113505 Vacuette Quickshield with Snappy Tube HolderGreiner Bio-One North America, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK173279 RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube…Myco Medical Supplies, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K173279RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube HolderMyco Medical Supplies, Inc. · 2018 · cites it directly0descendants
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 | K102774 | Vacuette Quickshield with Snappy Tude Holder | Greiner Bio-One North America, Inc. | 2010 | 1 |
| 0 (this device) | K113505 | Vacuette Quickshield with Snappy Tube Holder | Greiner Bio-One North America, Inc. | 2012 | — |
| +1 | 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 |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K102774 | Vacuette Quickshield with Snappy Tude HolderSummary page 1…le, Hypodermic, Single Lumen CFR Reference No. 21 CFR 880.5570 Product Code: FMI PREDICATE DEVICE: Greiner VACUETTE® QUICKSHIELD with SNAPPY Tube Holder - K102774 DEVICE DESCRIPTION: Intended Use: The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is to be used together only with V… | 2010 |
| † | K061483 | Vacuette Visio Plus Blood Collection Needles | 2006 |
| † | K973620 | Vacuette Multi-Sample Needle | 1997 |
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 |
|---|---|---|---|
| K173279 | RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder | 2018 | 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 15 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K173279 (Myco Medical Supplies, Inc., 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 with SNAPPY Tube Holder is to be used together only with VACUETTE® Blood Collection Needles and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these. instructions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113505: Vacuette Quickshield with Snappy Tube Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113505
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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