510(k) · Cleared
ClearedUnimax Veress Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unimax Medical Systems, Inc. · HIF Insufflator, Laparoscopic
Cleared on Aug 19, 2011 as substantially equivalent to K993625 (Genicon, LC, 2000) after an 87-day review. Its family tree reaches back 1 generation to 2000. 10 later devices descend from it.
- Decided
- Aug 19, 2011
- Review
- 87 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993625 (2000). 10 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK993625 Insufflation Needle- 120MM, Model 900-200Genicon, LC · 2000
- This deviceK111441 Unimax Veress NeedleUnimax Medical Systems, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK150068 Unimicro Veress NeedleUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015
- Descendant · cites it directly · 3 of its ownK171139 LaparoLight Veress NeedleBuffalo Filter, LLC · 2017
- Descendant · 2 generations on · 2 of its ownK232464 VereSee Optical Veres Needle SystemFreyja Healthcare, LLC · 2024
- Descendant · 2 generations on · 2 of its ownK172120 Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2017
- Descendant · 3 generations on · 1 of its ownK252640 VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K150068Unimicro Veress NeedleUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015 · cites it directly4descendants
- K171139LaparoLight Veress NeedleBuffalo Filter, LLC · 2017 · cites it directly3descendants
- K232464VereSee Optical Veres Needle SystemFreyja Healthcare, LLC · 2024 · 2 generations on2descendants
- K172120Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2017 · 2 generations on2descendants
- K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993625 | Insufflation Needle- 120MM, Model 900-200 | Genicon, LC | 2000 | — |
| 0 (this device) | K111441 | Unimax Veress Needle | Unimax Medical Systems, Inc. | 2011 | — |
| +1 | K150068 | Unimicro Veress Needle | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015 | — |
| +1 | K171139 | LaparoLight Veress Needle | Buffalo Filter, LLC | 2017 | — |
| +2 | K232464 | VereSee Optical Veres Needle System | Freyja Healthcare, LLC | 2024 | — |
| +2 | K172120 | Veress Needle | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017 | — |
| +3 | K252640 | VereSee Optical Veres Needle and Endoscopic Camera | Freyja Healthcare, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K993625 | Insufflation Needle- 120MM, Model 900-200Summary page 1…edicate Device Name: GeniCon Pneumo-Needle Manufacturer: GeniCon, L.C. 510(k) Number or Clearance Information: K993625 10… | 2000 |
What descends from it? (10)
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?
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Unimax 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/K111441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111441: Unimax Veress Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111441
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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