510(k) · Cleared
ClearedAfb (Absorbable Foam Buttress)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J&J Corporate Biomaterials Center · FTL Mesh, Surgical, Polymeric
Cleared on Jun 12, 2002 as substantially equivalent to K923657 (Bio-Vascular, Inc., 1992) and 9 other predicates after a 174-day review. Its family tree reaches back 4 generations to 1985. 145 later devices descend from it.
- Decided
- Jun 12, 2002
- Review
- 174 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 4 generations to K842066 (1985). 15 ancestors in all. 145 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 3 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 2 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 1 generation backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- This deviceK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- Descendant · cites it directly · 143 of its ownK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- Descendant · 2 generations on · 102 of its ownK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- Descendant · 2 generations on · 77 of its ownK043056 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004
- Descendant · 3 generations on · 69 of its ownK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- Descendant · 3 generations on · 48 of its ownK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
Showing 5 of 145 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 145 · See all- K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · cites it directly143descendants
- K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · 2 generations on102descendants
- K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004 · 2 generations on77descendants
- K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…Synovis Surgical Innovations · 2004 · 3 generations on69descendants
- K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP · 2008 · 3 generations on48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −3 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −2 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −1 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| 0 (this device) | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| +1 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| +2 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| +2 | K043056 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2004 | — |
| +3 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| +3 | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with… | Tyco Healthcare Group LP | 2008 | 24 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1994 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 7 | 0 |
| 2013 | 10 | 0 |
| 2014 | 10 | 0 |
| 2015 | 7 | 0 |
| 2016 | 10 | 0 |
| 2017 | 15 | 0 |
| 2018 | 10 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 0 |
| 2022 | 10 | 0 |
| 2023 | 9 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 9 | 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.
Planning a device in FTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | K923657 | Supple Peri-GuardSummary page 1…Bio-Vascular, Fen-Strips Dry03 R92 189.5 Inc . K923657 K940205… | 1992 |
| * | K940205 | Peri-StripsSummary page 1…Inc . K923657 K940205 K942583… | 1994 |
| * | K942583 | Peri-Strips Planar Configuration Staple Line ReinforcementSummary page 1…K940205 K942583 K97 1048 .… | 1994 |
| * | K971048 | Peri-Strips Dry - Staple Line ReinforcementSummary page 1…K942583 K97 1048 . K9925 37 W.L. Gore… | 1997 |
| * | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and…Summary page 1…K97 1048 . K9925 37 W.L. Gore SeamguardTM K955364… | 2000 |
| * | K955364 | Seamguard Staple Line Reinforcement MaterialSummary page 1…K9925 37 W.L. Gore SeamguardTM K955364 KO01789 Ethicon, Inc.… | 1996 |
| * | K001789 | Seamguard Staple Line Reinforcement Material | 2000 |
| * | K915835 | Coated Vicryl* IISummary page 1…KO01789 Ethicon, Inc. ’ Coated Vicryl XI K915835 Ethicon, Inc. Monocryl (poliglecaprone 25) K960653… | 1992 |
| * | K960653 | Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)Summary page 1…Ethicon, Inc. ’ Coated Vicryl XI K915835 Ethicon, Inc. Monocryl (poliglecaprone 25) K960653 suture, dyed IC964072 D. Device Descripti… | 1996 |
| * | K964072 | Monocryl (Poliglecaprone 25) Suture, UndyedSummary page 1…Ethicon, Inc. Monocryl (poliglecaprone 25) K960653 suture, dyed IC964072 D. Device Description: The AFB (Absorbable Foam Butkess) Reload is a sterile, single pat… | 1996 |
What descends from it? (145)
See all 1452 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K030782 (W. L. Gore & Associates, Inc., 2003) has gone furthest, with 143 descendants of its own.
- 8 other devices also cite its predicate K923657.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
AFB is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K014183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014183: Afb (Absorbable Foam Buttress).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014183
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026