510(k) · Cleared
ClearedU&U Sterile Hypodermic Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&U Medical Technology Co, Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Nov 13, 2013 as substantially equivalent to K070440 (Becton, Dickinson & CO, 2007) after a 91-day review. Its family tree reaches back 3 generations to 1993. 6 later devices descend from it.
- Decided
- Nov 13, 2013
- Review
- 91 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K931367 (1993). 10 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 2 generations backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- 1 generation backK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- This deviceK132552 U&U Sterile Hypodermic NeedleU&U Medical Technology Co, Ltd. · 2013
- Descendant · cites it directly · 4 of its ownK142765 TM Safety NeedleThinkmed Medical Technology Co., Ltd. · 2015
- Descendant · 2 generations on · 3 of its ownK191644 TK Safety NeedleAnhui Tiankang Medical Technology Co., Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK231723 Sterile Safety Hypodermic Needles for Single UseWepon Medical Technology Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK220603 Disposable Medical Safety Hypodermic NeedleHantech Medical Device Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK213535 Sterile Safety Hypodermic Needles for Single UseZhejiang Kangkang Medical-Devices Co., Ltd. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K142765TM Safety NeedleThinkmed Medical Technology Co., Ltd. · 2015 · cites it directly4descendants
- K191644TK Safety NeedleAnhui Tiankang Medical Technology Co., Ltd. · 2020 · 2 generations on3descendants
- K231723Sterile Safety Hypodermic Needles for Single UseWepon Medical Technology Co., Ltd. · 2023 · 3 generations on0descendants
- K220603Disposable Medical Safety Hypodermic NeedleHantech Medical Device Co., Ltd. · 2022 · 3 generations on0descendants
- K213535Sterile Safety Hypodermic Needles for Single UseZhejiang Kangkang Medical-Devices Co., Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −2 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| −1 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| 0 (this device) | K132552 | U&U Sterile Hypodermic Needle | U&U Medical Technology Co, Ltd. | 2013 | — |
| +1 | K142765 | TM Safety Needle | Thinkmed Medical Technology Co., Ltd. | 2015 | — |
| +2 | K191644 | TK Safety Needle | Anhui Tiankang Medical Technology Co., Ltd. | 2020 | — |
| +3 | K231723 | Sterile Safety Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. | 2023 | — |
| +3 | K220603 | Disposable Medical Safety Hypodermic Needle | Hantech Medical Device Co., Ltd. | 2022 | — |
| +3 | K213535 | Sterile Safety Hypodermic Needles for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K070440 | BD Hypoint NeedleSummary page 1…lation Number: 880 5570 3. Predicate Devices Information: Hypodermic Needle: Trade Name: BD Hypaintm Hypodermic Needle. 510(K) Number: K070440 4. Devices Description: U&U Sterile Hypodermic Needle The U&U Sterile Hypodermic Needle Isa hypodermic single lumen needle, des… | 2007 |
What descends from it? (6)
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 20 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K142765 (Thinkmed Medical Technology Co., Ltd., 2015) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K070440.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
U&U Sterile Hypodermic Needles is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132552: U&U Sterile Hypodermic Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132552
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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