510(k) · Cleared
ClearedAragon Surgical Lapcap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aragon Surgical, Inc. · HIF Insufflator, Laparoscopic
Cleared on May 30, 2007 as substantially equivalent to K061387 (Veresure, Inc., 2006) and 1 other predicate after an 82-day review. Its family tree reaches back 2 generations to 1985. 4 later devices descend from it.
- Decided
- May 30, 2007
- Review
- 82 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K852726 (1985). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK852726 Allis Tissue Forceps, 4X5 Teeth, 6+SS 410 or 420The Huxley Instrument Corp. · 1985
- 1 generation backK061387 Veresure BellVeresure, Inc. · 2006
- This deviceK070651 Aragon Surgical LapcapAragon Surgical, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK233020 TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group Research & Development, Co., LLC · 2024
- Descendant · cites it directly · 1 of its ownK073452 Modification to: Aragon Surgical LapcapAragon Surgical, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK242536 TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group · 2024
- Descendant · 2 generations on · 0 of its ownK212786 LevaLap Laparoscopic Access DeviceCore Access Surgical Technologies, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See all- K233020TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group Research & Development, Co., LLC · 2024 · cites it directly1descendant
- K073452Modification to: Aragon Surgical LapcapAragon Surgical, Inc. · 2008 · cites it directly1descendant
- K242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group · 2024 · 2 generations on0descendants
- K212786LevaLap Laparoscopic Access DeviceCore Access Surgical Technologies, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852726 | Allis Tissue Forceps, 4X5 Teeth, 6+SS 410 or 420 | The Huxley Instrument Corp. | 1985 | — |
| −1 | K061387 | Veresure Bell | Veresure, Inc. | 2006 | — |
| 0 (this device) | K070651 | Aragon Surgical Lapcap | Aragon Surgical, Inc. | 2007 | — |
| +1 | K233020 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Research & Development, Co., LLC | 2024 | — |
| +1 | K073452 | Modification to: Aragon Surgical Lapcap | Aragon Surgical, Inc. | 2008 | — |
| +2 | K242536 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group | 2024 | — |
| +2 | K212786 | LevaLap Laparoscopic Access Device | Core Access Surgical Technologies, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K061387 | Veresure BellSummary page 1…edures. Equivalent Device: The subject device is substantially equivalent in intended use/technological characteristics and/or method of operation to the Veresure Bell (K061387) and the Taut - Insufflation Needle (K003703). Summary: Based on the intended use and technological characteristics informatio… | 2006 |
| * | K003703 | Taut-Insufflation NeedleSummary page 1…is substantially equivalent in intended use/technological characteristics and/or method of operation to the Veresure Bell (K061387) and the Taut - Insufflation Needle (K003703). Summary: Based on the intended use and technological characteristics information provided in this notification, the subject de… | 2001 |
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 22 years and passes through 3 companies; a new generation was cleared every 21.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K233020 (Tautona Group Research & Development, Co., LLC, 2024) has gone furthest, with 1 descendant 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. 2007, 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 Aragon Surgical LapCap is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070651: Aragon Surgical Lapcap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070651
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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