# K920547: Ultra-Thin

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: May 6, 1992 after 90 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 2 cite it directly.
2 of 18 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
- K965183: Vantage Peripheral Dilatation Catheter (1997), 13 descendants of its own
- K983830: Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter (1999), 12 descendants of its own
- K022212: Portex Percutaneous Dilatational Tracheostomy Kits (2003), 10 descendants of its own
- K040014: Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for Sizes 7, 8 and 9MM Tubes Only (2004), 6 descendants of its own
- K041348: Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line Ultra (2004), 5 descendants of its own

Source page: https://510kreport.com/device/K920547
Methodology: https://510kreport.com/methodology