510(k) · Cleared
Recalled · Class II · 2014Elutia Coated Closed Surgical Wound Drain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bacterin International, Inc. · OEI Drainage Catheter With Antibiotic
Cleared on Nov 28, 2007 as substantially equivalent to K953655 (Johnson & Johnson Medical, Inc., 1995) and 3 other predicates after a 398-day review. Its family tree reaches back 7 generations to 1998. 3 of the 17 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times.
- Decided
- Nov 28, 2007
- Review
- 398 days
- Class
- Class II
- Product code
- OEI
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 7 generations to K981994 (1998). 16 ancestors in all, the oldest K895417 (1990). No later device cites it as a predicate yet. 3 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
- 6 generations backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
- 5 generations backK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
- 4 generations backK030020 Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2003
- 3 generations backK033294 Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM…C.R. Bard, Inc. · 2003
- 2 generations backK051748 Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis…C.R. Bard, Inc. · 2005 · Recalled
- 1 generation backK053589 Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc. · 2006
- This deviceK063245 Elutia Coated Closed Surgical Wound DrainBacterin International, Inc. · 2007
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K981994 | Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter | C.R. Bard, Inc. | 1998 | — |
| −6 | K012562 | Medcomp 14.5F Double Lumen Hemodialysis Catheter | Medical Components, Inc. | 2002 | — |
| −5 | K020465 | Medcomp Ash Split-Cath II | Medcomp | 2002 | — |
| −4 | K030020 | Hemosplit Long-Term Hemodialysis Catheter | C.R. Bard, Inc. | 2003 | — |
| −3 | K033294 | Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with… | C.R. Bard, Inc. | 2003 | — |
| −2 | K051748 | Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters | C.R. Bard, Inc. | 2005 | 13 |
| −1 | K053589 | Long-Term Hemodialysis Catheters with Biobloc Coating | Bard Access Systems, Inc. | 2006 | — |
| 0 (this device) | K063245 | Elutia Coated Closed Surgical Wound Drain | Bacterin International, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 2 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 1 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953655 | J-Vac Suction Reservoirs & J-Vac Blake Silicone DrainsSummary page 1…2(a)(3)] The following predicate devices have been identi fied: Wound Drain Comparison * Johnson &Johnson/Ethicon J-VAC Surgical Wound Drain -K953655 The subject device is similar to the J&J J-VAC Surgical Wound Drain with regard to length, diameter, radi… | 1995 |
| * | K900263 | Antimicrobial Multi-Lumen Central Venous CatheterSummary page 1…Wound Drain has a hydrogel coating containing silver sulfadiazine. Silver Coating * Arrow Blue Central Venous Catheter (Silver Coated) -K900263 * Bard Dialysis Catheter with BioBloc Coating - K053589 * Sil-Med Flat Suction Drain/Kit with Spi-Argen… | 1990 |
| * | K053589 | Long-Term Hemodialysis Catheters with Biobloc CoatingSummary page 1…adiazine. Silver Coating * Arrow Blue Central Venous Catheter (Silver Coated) -K900263 * Bard Dialysis Catheter with BioBloc Coating - K053589 * Sil-Med Flat Suction Drain/Kit with Spi-Argent HI- K961295 The subject device is coated with silver sul… | 2006 |
| * | K961295 | Sapphire Line Flat Drain/Kit with Spi-Argent II W/or W/Out TrocarSummary page 1…Catheter (Silver Coated) -K900263 * Bard Dialysis Catheter with BioBloc Coating - K053589 * Sil-Med Flat Suction Drain/Kit with Spi-Argent HI- K961295 The subject device is coated with silver sulfadiazine. The predicate devices are coated with silver sulfa… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 15, 2014 | Class II | Z-1680-2014 | Use error | 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 sterilized |
| Jan 28, 2013 | Class II | Z-0936-2013 | Nonconforming Material/Component | A portion of a silicone wound drain was found to be cracked. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · Direct predicate · ◆ in the 1990 ancestors bar of FIG. 12 Class I recalls
- K99393314 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume…Arrow Intl., Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K895417Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · 3 generations back · ◆ in the 1990 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 16 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All OEI devicesOEI Drainage Catheter With Antibiotic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OEI
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · OEI
Too few OEI 510(k)s in any year since 2007 to give a median.
Recalls per year · OEI
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OEI
2in 2017
MAUDE reports naming product code OEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063245 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063245: Elutia Coated Closed Surgical Wound Drain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063245
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026