# K213773: Insufflation Retention Device

- Pathway: 510(k) (Traditional)
- Applicant: Bpendo, LLC
- Decided: Jul 21, 2022 after 231 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K993704 (2000). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162428: DiLumen Endolumenal Interventional Platform, Lumendi, LLC (2016) Summary page 4.

## Most influential descendants
- K261587: Insufflation Retention Device (IRD) (11173-325-101) (2026), 0 descendants of its own

## Indications for use
The Insufflation Retention Device (IRD) is an accessory to an endoscope. The IRD is a single balloon accessory intended for use with any standard endoscope that has a distal tip outer diameter of 9.2-13.2 mm. The device is indicated to assist with optical visualization in the large intestine during endoscopic procedures.

Source page: https://510kreport.com/device/K213773
Methodology: https://510kreport.com/methodology