# K063245: Elutia  Coated Closed Surgical Wound Drain

- Pathway: 510(k) (Traditional)
- Applicant: Bacterin International, Inc.
- Decided: Nov 28, 2007 after 398 days
- Product code: OEI (Drainage Catheter With Antibiotic)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K981994 (1998). 16 ancestors in all.
No later device cites it as a predicate yet.
3 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953655: J-Vac Suction Reservoirs & J-Vac Blake Silicone Drains, Johnson & Johnson Medical, Inc. (1995) Summary page 1.
- K900263: Antimicrobial Multi-Lumen Central Venous Catheter, Arrow Intl., Inc. (1990) Summary page 1.
- K053589: Long-Term Hemodialysis Catheters with Biobloc Coating, Bard Access Systems, Inc. (2006) Summary page 1.
- K961295: Sapphire Line Flat Drain/Kit with Spi-Argent II W/or W/Out Trocar, Sil-Med Corp. (1996) Summary page 1.

## Recalls of this device
- May 15, 2014 · Class II · Z-1680-2014: The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. All of the affected products were appropriately st
- Jan 28, 2013 · Class II · Z-0936-2013: A portion of a silicone wound drain was found to be cracked.

## Indications for use
The subject device is intended for the evacuation of biological fluids from wounds or body cavities. Closed wound drainage systems have been used by various surgical specialties, including: orthopedic, general, reconstructive, neurological, gynecological, head and neck, thoracic / cardiovascular, and plastic surgery.

Source page: https://510kreport.com/device/K063245
Methodology: https://510kreport.com/methodology