# K213552: PuraStat-RM

- Pathway: 510(k) (Traditional)
- Applicant: 3-D Matrix, Inc.
- Decided: Apr 1, 2022 after 144 days
- Product code: PHN (Protective Coating, Mucoadhesive Application, For The Rectal Mucosa)
- Device class: U
- 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 K964852 (1997). 11 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140558: Proctigard, Access Pharmaceuticals, Inc. (2014) Summary page 4.
- K210211: PuraStat-OM, 3-D Matrix, Inc. (2021) Summary page 4.

## Most influential descendants
- K242634: PuraStat (2025), 2 descendants of its own
- K253923: PuraStat (2026), 1 descendant of its own
- K261504: PuraStat-RM (2026), 0 descendants of its own

## Indications for use
PuraStat-RM is indicated for the symptomatic management of rectal mucositis, such as radiation proctitis that may be caused by chemotherapy or radiotherapy.

Source page: https://510kreport.com/device/K213552
Methodology: https://510kreport.com/methodology