510(k) · Cleared
ClearedGenoss Collagen Membrane Model GCM1020, GCM3040 Total 6 Models
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genoss Co., Ltd. · NPL Barrier, Animal Source, Intraoral
Cleared on May 4, 2011 as substantially equivalent to K003339 (Collagen Matrix, Inc., 2001) and 2 other predicates after a 261-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- May 4, 2011
- Review
- 261 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K921895 (1992). 15 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 5 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 4 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 3 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 2 generations backK021105 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 1 generation backK071555 Fortagen Oral MembraneOrganogenesis, Inc. · 2007
- This deviceK102307 Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 ModelsGenoss Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −4 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −3 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −2 | K021105 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −1 | K071555 | Fortagen Oral Membrane | Organogenesis, Inc. | 2007 | — |
| 0 (this device) | K102307 | Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 Models | Genoss Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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.
Planning a device in NPL? 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 NPL device
- #1 K212463 Geistlich Bio-Gide, Geistlich Bio-Gide Shape…score 14.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K003339 | Collagen Periodontal MembraneSummary page 1…on name: Resorbable dental barrier membrane, animal source Classification name: Barrier, animal source, dental 3. Predicated Device RCM6 membrane (K003339) Fortgen Oral Membrane (K07 1555) OSSIX Plus (K053260) 4. Description GENOSS Collagen Membrane is a resorbable mem… | 2001 |
| * | K071555 | Fortagen Oral MembraneSummary page 1…barrier membrane, animal source Classification name: Barrier, animal source, dental 3. Predicated Device RCM6 membrane (K003339) Fortgen Oral Membrane (K07 1555) OSSIX Plus (K053260) 4. Description GENOSS Collagen Membrane is a resorbable membrane to aid the regenerative healing… | 2007 |
| * | K053260 | Ossix -PlusSummary page 1…source Classification name: Barrier, animal source, dental 3. Predicated Device RCM6 membrane (K003339) Fortgen Oral Membrane (K07 1555) OSSIX Plus (K053260) 4. Description GENOSS Collagen Membrane is a resorbable membrane to aid the regenerative healing of bone or bone/peri… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 15 ancestors have a recall of any class.
- 2 other devices also cite its predicate K003339.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NPL
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPL
132in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPL
6in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPL
39in 2025
MAUDE reports naming product code NPL, 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 | 4 | 172 | 0 | 0 |
| 2009 | 3 | 193 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 4 | 286 | 0 | 0 |
| 2012 | 0 | — | 3 | 3 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 5 | 140 | 0 | 3 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 3 | 184 | 0 | 9 |
| 2017 | 3 | 200 | 0 | 18 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 1 | — | 6 | 22 |
| 2020 | 2 | — | 0 | 8 |
| 2021 | 2 | — | 0 | 11 |
| 2022 | 3 | 290 | 0 | 19 |
| 2023 | 2 | — | 0 | 5 |
| 2024 | 3 | 263 | 0 | 20 |
| 2025 | 5 | 132 | 0 | 39 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
GENOSS Collagen Membrane is intended to be used during guided bone and guided tissue regeneration procedures as a biodegradable barrier membrane into bony defects surrounding teeth and on alveolar ridges.
- Periodontal/infirabony defects
- Ridge augmentation
- Extraction sites (implant preparation/placement)
- Guided bone regeneration (GBR) procedures
- Sinus lifts
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102307: Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 Models.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102307
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