510(k) · Cleared
ClearedInsufflation Needle- 120MM, Model 900-200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genicon, LC · HIF Insufflator, Laparoscopic
Cleared on Jun 20, 2000 after a 238-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Jun 20, 2000
- Review
- 238 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK993625 Insufflation Needle- 120MM, Model 900-200Genicon, LC · 2000
- Descendant · cites it directly · 10 of its ownK111441 Unimax Veress NeedleUnimax Medical Systems, Inc. · 2011
- Descendant · 2 generations on · 4 of its ownK150068 Unimicro Veress NeedleUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015
- Descendant · 2 generations on · 3 of its ownK171139 LaparoLight Veress NeedleBuffalo Filter, LLC · 2017
- Descendant · 3 generations on · 2 of its ownK232464 VereSee Optical Veres Needle SystemFreyja Healthcare, LLC · 2024
- Descendant · 3 generations on · 2 of its ownK172120 Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K111441Unimax Veress NeedleUnimax Medical Systems, Inc. · 2011 · cites it directly10descendants
- K150068Unimicro Veress NeedleUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015 · 2 generations on4descendants
- K171139LaparoLight Veress NeedleBuffalo Filter, LLC · 2017 · 2 generations on3descendants
- K232464VereSee Optical Veres Needle SystemFreyja Healthcare, LLC · 2024 · 3 generations on2descendants
- K172120Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2017 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993625 | Insufflation Needle- 120MM, Model 900-200 | Genicon, LC | 2000 | — |
| +1 | K111441 | Unimax Veress Needle | Unimax Medical Systems, Inc. | 2011 | — |
| +2 | K150068 | Unimicro Veress Needle | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015 | — |
| +2 | K171139 | LaparoLight Veress Needle | Buffalo Filter, LLC | 2017 | — |
| +3 | K232464 | VereSee Optical Veres Needle System | Freyja Healthcare, LLC | 2024 | — |
| +3 | K172120 | Veress Needle | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Apple Medical’s Pneumo-Matic Insufflation Needle Named without a submission number |
What descends from it? (12)
See all 122 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?
- Of its descendants, K111441 (Unimax Medical Systems, Inc., 2011) has gone furthest, with 10 descendants of its own.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 GeniCon Pnugmo — Needle is intended for percutancous insertion into the peritoneal cavity for the purspose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993625 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993625: Insufflation Needle- 120MM, Model 900-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993625
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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