510(k) · Cleared
ClearedUnimicro Veress Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unimicro Medical Systems (Shenzhen) Co., Ltd. · HIF Insufflator, Laparoscopic
Cleared on Jul 31, 2015 as substantially equivalent to K111441 (Unimax Medical Systems, Inc., 2011) after a 199-day review. Its family tree reaches back 2 generations to 2000. 4 later devices descend from it.
- Decided
- Jul 31, 2015
- Review
- 199 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K993625 (2000). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK993625 Insufflation Needle- 120MM, Model 900-200Genicon, LC · 2000
- 1 generation backK111441 Unimax Veress NeedleUnimax Medical Systems, Inc. · 2011
- This deviceK150068 Unimicro Veress NeedleUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK172120 Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2017
- Descendant · 2 generations on · 1 of its ownK193339 GTK Veress NeedlesGuangzhou T.K Medical Instrument Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK232401 Disposable Veress NeedlesHangzhou Kangji Medical Instrument Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK231407 StarFinPremium Medical Technology, LLC · 2023
Most influential descendants
Showing 4 of 4 · See all- K172120Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2017 · cites it directly2descendants
- K193339GTK Veress NeedlesGuangzhou T.K Medical Instrument Co., Ltd. · 2020 · 2 generations on1descendant
- K232401Disposable Veress NeedlesHangzhou Kangji Medical Instrument Co., Ltd. · 2023 · cites it directly0descendants
- K231407StarFinPremium Medical Technology, LLC · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993625 | Insufflation Needle- 120MM, Model 900-200 | Genicon, LC | 2000 | — |
| −1 | K111441 | Unimax Veress Needle | Unimax Medical Systems, Inc. | 2011 | — |
| 0 (this device) | K150068 | Unimicro Veress Needle | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015 | — |
| +1 | K172120 | Veress Needle | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017 | — |
| +2 | K193339 | GTK Veress Needles | Guangzhou T.K Medical Instrument Co., Ltd. | 2020 | — |
| +1 | K232401 | Disposable Veress Needles | Hangzhou Kangji Medical Instrument Co., Ltd. | 2023 | — |
| +3 | K231407 | StarFin | Premium Medical Technology, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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 HIF? 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 HIF device
- #1 K250388 Endoflator +score 15.8 · 10 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 |
|---|---|---|---|
| * | K111441 | Unimax Veress NeedleSummary page 5…21CFR Veress Needle Medical HIF 884.1730 K111441 Needle Systems Inc. Class II, 21CFR F… | 2011 |
What descends from it? (4)
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 15 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K172120 (Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd, 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K111441.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HIF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIF
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIF
12so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HIF
1,507in 2025
MAUDE reports naming product code HIF, 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 | 4 | 140 | 0 | 8 |
| 2008 | 2 | — | 1 | 14 |
| 2009 | 4 | 191 | 0 | 21 |
| 2010 | 2 | — | 0 | 41 |
| 2011 | 5 | 128 | 0 | 44 |
| 2012 | 5 | 138 | 0 | 38 |
| 2013 | 2 | — | 0 | 40 |
| 2014 | 2 | — | 0 | 43 |
| 2015 | 2 | — | 0 | 30 |
| 2016 | 3 | 88 | 1 | 72 |
| 2017 | 5 | 242 | 0 | 68 |
| 2018 | 3 | 207 | 1 | 97 |
| 2019 | 2 | — | 0 | 128 |
| 2020 | 4 | 64 | 0 | 360 |
| 2021 | 1 | — | 0 | 654 |
| 2022 | 1 | — | 0 | 667 |
| 2023 | 7 | 134 | 1 (1) | 890 |
| 2024 | 4 | 170 | 0 | 1,483 |
| 2025 | 3 | 210 | 0 | 1,507 |
| 2026 | 3 | 265 | 12 | — |
What is it indicated for?
The Unimicro Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150068 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150068: Unimicro Veress Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150068
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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