# K132198: Adaptain, Adaptain Fastwrap, Envelock, Biowai

- Pathway: 510(k) (Traditional)
- Applicant: Ceremed, Inc.
- Decided: Sep 12, 2013 after 58 days
- Product code: KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K791495 (1979). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122561: Adaptain Fastwrap, Envelock, Graftain, Ceremed, Inc. (2012) Summary page 2.

## Indications for use
Adaptain is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.

Source page: https://510kreport.com/device/K132198
Methodology: https://510kreport.com/methodology