# K003703: Taut-Insufflation Needle

- Pathway: 510(k) (Traditional)
- Applicant: Taut, Inc.
- Decided: Feb 22, 2001 after 83 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K061387: Veresure Bell (2006), 5 descendants of its own
- K070651: Aragon Surgical Lapcap (2007), 4 descendants of its own
- K233020: TauTona Pneumoperitoneum Assist Device (TPAD) (2024), 1 descendant of its own
- K073452: Modification to: Aragon Surgical Lapcap (2008), 1 descendant of its own
- K242536: TauTona Pneumoperitoneum Assist Device (TPAD) (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K003703
Methodology: https://510kreport.com/methodology