510(k) · Cleared
ClearedDisposable Insulin Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Berpu Medical Technology Co., Ltd. · FMF Syringe, Piston
Cleared on Dec 29, 2016 as substantially equivalent to K072739 (Shandong Weigao Group Medical Polymer Co., Ltd., 2008) after a 147-day review. Its family tree reaches back 4 generations to 1993. 5 later devices descend from it.
- Decided
- Dec 29, 2016
- Review
- 147 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K931367 (1993). 20 ancestors in all, the oldest K822083 (1982). 5 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 3 generations backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- 2 generations backK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- 1 generation backK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
- This deviceK162180 Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK193273 Insulin SyringePromisemed Hangzhou Meditech Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK222672 Disposable Insulin SyringeHantech Medical Device Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK203211 Insulin syringe with integrated needle DLDlp Medical Products, Corp. · 2023
- Descendant · cites it directly · 0 of its ownK221045 Insulin Syringes without needleBerpu Medical Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK210712 Verifine Mechanical Safety Insulin SyringePromisemed Hangzhou Meditech Co., Ltd. · 2021
Most influential descendants
Showing 5 of 5 · See all- K193273Insulin SyringePromisemed Hangzhou Meditech Co., Ltd. · 2021 · cites it directly2descendants
- K222672Disposable Insulin SyringeHantech Medical Device Co., Ltd. · 2023 · 2 generations on0descendants
- K203211Insulin syringe with integrated needle DLDlp Medical Products, Corp. · 2023 · cites it directly0descendants
- K221045Insulin Syringes without needleBerpu Medical Technology Co., Ltd. · 2022 · cites it directly0descendants
- K210712Verifine Mechanical Safety Insulin SyringePromisemed Hangzhou Meditech Co., Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −3 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| −2 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| −1 | K072739 | Jierui Syringes and Needles | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008 | — |
| 0 (this device) | K162180 | Disposable Insulin Syringe | Berpu Medical Technology Co., Ltd. | 2016 | — |
| +1 | K193273 | Insulin Syringe | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| +2 | K222672 | Disposable Insulin Syringe | Hantech Medical Device Co., Ltd. | 2023 | — |
| +1 | K203211 | Insulin syringe with integrated needle DL | Dlp Medical Products, Corp. | 2023 | — |
| +1 | K221045 | Insulin Syringes without needle | Berpu Medical Technology Co., Ltd. | 2022 | — |
| +2 | K210712 | Verifine Mechanical Safety Insulin Syringe | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 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 |
|---|---|---|---|
| * | K072739 | Jierui Syringes and NeedlesSummary page 5…re provided sterile, single use. The proposed device is available in 0.3ml, 0.5ml and 1ml volumes. 5. Identification of Predicate Device 510(k) Number: K072739 Product Name: Sterile Insulin Syringe for single use with fixed needle Manufacturer: ShanDong Weigao Group Medical Poly… | 2008 |
What descends from it? (5)
3 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 23 years and passes through 5 companies; a new generation was cleared every 8.8 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K193273 (Promisemed Hangzhou Meditech Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 10 other devices also cite its predicate K072739.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The disposable insulin syringe is intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of insulin into parts of the body below the surface skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162180 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162180: Disposable Insulin Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162180
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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