510(k) · Cleared
ClearedSterile Blunt for Single Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Double Dove Industrial Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Oct 18, 2012 as substantially equivalent to K102328 (Shandong Weigao Group Medical Polymer Co., Ltd., 2011) after a 251-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Oct 18, 2012
- Review
- 251 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K920422 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK920422 B-D Interlink Syringe CannulaBd Becton Dickinson Vacutainer Systems Preanalytic · 1992
- 2 generations backK974006 Becton Dickinson TwinpakBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
- 1 generation backK102328 Blunt Fill Needle and Blunt Plastic CannulaShandong Weigao Group Medical Polymer Co., Ltd. · 2011
- This deviceK120420 Sterile Blunt for Single UseShanghai Double Dove Industrial Co., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920422 | B-D Interlink Syringe Cannula | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992 | — |
| −2 | K974006 | Becton Dickinson Twinpak | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | — |
| −1 | K102328 | Blunt Fill Needle and Blunt Plastic Cannula | Shandong Weigao Group Medical Polymer Co., Ltd. | 2011 | — |
| 0 (this device) | K120420 | Sterile Blunt for Single Use | Shanghai Double Dove Industrial Co., Ltd. | 2012 | — |
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 |
|---|---|---|---|
| * | K102328 | Blunt Fill Needle and Blunt Plastic CannulaSummary page 3…Conclusion The proposed device, Sterile Blunt for Single Use, has same intended use, configuration, operation mode with those of the predicate device, Blunts (K102328). The materials are different, the biocompatibility test and leachable substance analysis d'emonstrated that the materails… | 2011 |
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 20 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 3 ancestors has a recall.
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?
Sterile Blunt for Single Use includes two models, which are blunt fill needle and blunt plastic cannula.
The blunt fill needle is used in conjunction with a syringe to penetrate the vial/ampoules stopper for injection or aspiration of fluid.
The blunt plastic cannula is used in conjunction with a syringe to access the pre-slit septum covering injection sites on IV System intended for injection or aspiration of fluid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120420: Sterile Blunt for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120420
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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