510(k) · Cleared
ClearedTaut-Insufflation Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taut, Inc. · HIF Insufflator, Laparoscopic
Cleared on Feb 22, 2001 after an 83-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Feb 22, 2001
- Review
- 83 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK003703 Taut-Insufflation NeedleTaut, Inc. · 2001
- Descendant · cites it directly · 5 of its ownK061387 Veresure BellVeresure, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK070651 Aragon Surgical LapcapAragon Surgical, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK233020 TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group Research & Development, Co., LLC · 2024
- Descendant · 2 generations on · 1 of its ownK073452 Modification to: Aragon Surgical LapcapAragon Surgical, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK242536 TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K061387Veresure BellVeresure, Inc. · 2006 · cites it directly5descendants
- K070651Aragon Surgical LapcapAragon Surgical, Inc. · 2007 · cites it directly4descendants
- K233020TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group Research & Development, Co., LLC · 2024 · 2 generations on1descendant
- K073452Modification to: Aragon Surgical LapcapAragon Surgical, Inc. · 2008 · 2 generations on1descendant
- K242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003703 | Taut-Insufflation Needle | Taut, Inc. | 2001 | — |
| +1 | K061387 | Veresure Bell | Veresure, Inc. | 2006 | — |
| +1 | K070651 | Aragon Surgical Lapcap | Aragon Surgical, Inc. | 2007 | — |
| +2 | K233020 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Research & Development, Co., LLC | 2024 | — |
| +2 | K073452 | Modification to: Aragon Surgical Lapcap | Aragon Surgical, Inc. | 2008 | — |
| +3 | K242536 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
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?
- Of its descendants, K061387 (Veresure, Inc., 2006) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K003703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003703: Taut-Insufflation Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003703
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026