510(k) · Cleared
ClearedBlood Collection Needle, Model 20G 21G 22G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shandong Weigao Group Medical Polymer Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Dec 20, 2007 as substantially equivalent to K061483 (Greiner Bio-One North America, Inc., 2006) after a 44-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Dec 20, 2007
- Review
- 44 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950159 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK950159 SuresharpGainor Medical U.S.A., Inc. · 1995
- 2 generations backK973620 Vacuette Multi-Sample NeedleGreiner Meditech, Inc. · 1997
- 1 generation backK061483 Vacuette Visio Plus Blood Collection NeedlesGreiner Bio-One North America, Inc. · 2006
- This deviceK073127 Blood Collection Needle, Model 20G 21G 22GShandong Weigao Group Medical Polymer Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK103587 Disposable Bllod Collection NeedleWeihai Hongyu Medical Devices Co., Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K103587Disposable Bllod Collection NeedleWeihai Hongyu Medical Devices Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950159 | Suresharp | Gainor Medical U.S.A., Inc. | 1995 | — |
| −2 | K973620 | Vacuette Multi-Sample Needle | Greiner Meditech, Inc. | 1997 | — |
| −1 | K061483 | Vacuette Visio Plus Blood Collection Needles | Greiner Bio-One North America, Inc. | 2006 | — |
| 0 (this device) | K073127 | Blood Collection Needle, Model 20G 21G 22G | Shandong Weigao Group Medical Polymer Co., Ltd. | 2007 | — |
| +1 | K103587 | Disposable Bllod Collection Needle | Weihai Hongyu Medical Devices Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K061483 | Vacuette Visio Plus Blood Collection NeedlesSummary page 1…-21-64264467 x 152 Fax: +86-21-64264468 x 809 Email: Diana.hong~mid-link.net Eric.chen~mid-link.net 3. Predicate Device K number: K(061483 Trade Name: VACUETTES VISIO PLUS Blood Collection Needles Common Name: Blood Collection Needles… | 2006 |
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 |
|---|---|---|---|
| K103587 | Disposable Bllod Collection Needle | 2011 | 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 12 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103587 (Weihai Hongyu Medical Devices Co., Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K061483.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Blood Collection Needles is designed for use in the daily blood collection routine when delegated by a qualified practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073127: Blood Collection Needle, Model 20G 21G 22G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073127
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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