510(k) · Cleared
ClearedStarFin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Premium Medical Technology, LLC · HIF Insufflator, Laparoscopic
Cleared on Aug 29, 2023 as substantially equivalent to K193339 (Guangzhou T.K Medical Instrument Co., Ltd., 2020) and 1 other predicate after a 106-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Aug 29, 2023
- Review
- 106 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K993625 (2000). 6 ancestors in all, the oldest K954853 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK993625 Insufflation Needle- 120MM, Model 900-200Genicon, LC · 2000
- 4 generations backK111441 Unimax Veress NeedleUnimax Medical Systems, Inc. · 2011
- 3 generations backK150068 Unimicro Veress NeedleUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015
- 2 generations backK172120 Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2017
- 1 generation backK193339 GTK Veress NeedlesGuangzhou T.K Medical Instrument Co., Ltd. · 2020
- This deviceK231407 StarFinPremium Medical Technology, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K993625 | Insufflation Needle- 120MM, Model 900-200 | Genicon, LC | 2000 | — |
| −4 | K111441 | Unimax Veress Needle | Unimax Medical Systems, Inc. | 2011 | — |
| −3 | K150068 | Unimicro Veress Needle | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015 | — |
| −2 | K172120 | Veress Needle | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017 | — |
| −1 | K193339 | GTK Veress Needles | Guangzhou T.K Medical Instrument Co., Ltd. | 2020 | — |
| 0 (this device) | K231407 | StarFin | Premium Medical Technology, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (2)
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 |
|---|---|---|---|
| * | K193339 | GTK Veress NeedlesSummary page 4…lation Number: 21 CFR 884 1730 Regulation Name: Laparoscopic Insufflator Product Code: HIF and GCJ Regulatory Class: Class II 3. Predicate Devices 510(K): K193339 Device Name: GTK Veress Needle 510(K): K954853 Device Name: Endo-CloseTM Auto-SutureTM Trocar Site Closure Device Th… | 2020 |
| * | K954853 | Auto Suture Suture ClosureSummary page 4…aroscopic Insufflator Product Code: HIF and GCJ Regulatory Class: Class II 3. Predicate Devices 510(K): K193339 Device Name: GTK Veress Needle 510(K): K954853 Device Name: Endo-CloseTM Auto-SutureTM Trocar Site Closure Device The predicates have not been subject to a design-related… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 companies; a new generation was cleared every 3.6 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 StarFin device is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum for laparoscopic procedures prior to the placement of trocars. The StarFin device is also used for suture capture, passing, externalization and internalization for wound closure after laparoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231407 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231407: StarFin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231407
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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