510(k) · Cleared
ClearedGeistlich Bio-Flow®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geistlich Pharma AG · NPM Bone Grafting Material, Animal Source
Cleared on Mar 7, 2025 as substantially equivalent to K122894 (Geistlich Pharma AG, 2013) after a 196-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Mar 7, 2025
- Review
- 196 days
- Class
- Class II
- Product code
- NPM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924408 (1995). 16 ancestors in all, the oldest K871773 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 5 generations backK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
- 4 generations backK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
- 3 generations backK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
- 2 generations backK112572 Geistlich Combi-Kit CollegenGeistlich Pharma AG · 2011
- 1 generation backK122894 Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit…Geistlich Pharma AG · 2013
- This deviceK242510 Geistlich Bio-Flow®Geistlich Pharma AG · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | 1995 | 2 |
| −5 | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen… | Integra Lifesciences Corp. | 1999 | 1 |
| −4 | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004 | — |
| −3 | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005 | — |
| −2 | K112572 | Geistlich Combi-Kit Collegen | Geistlich Pharma AG | 2011 | — |
| −1 | K122894 | Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen… | Geistlich Pharma AG | 2013 | — |
| 0 (this device) | K242510 | Geistlich Bio-Flow® | Geistlich Pharma AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 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 NPM? 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 NPM device
- #1 K240661 Geistlich Bio-Oss®score 15.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K122894 | Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich…Summary page 5…ivalence is claimed to the following device: Product Name 510(k) Applicant Geistlich Bio-Oss® Collagen K122894 Geistlich Pharma AG Reference devices: • Geistlich Bio-Oss®, K240661, Geistlich Pharma AG • Geistlich B… | 2013 |
| † | K240661 | Geistlich Bio-Oss® | 2024 |
| † | K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich… | 2022 |
| † | K120601 | Geistlich Bio-Oss Pen (0.25 G, 0.25-1.0MM Granules), Geistlich Bio-Oss Pen (0.5 G… | 2012 |
| † | K091484 | Novabone Dental Putty - Bioactive Synthetic Bone Graft | 2009 |
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 30 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 16 ancestors have a recall of any class.
- 9 other devices also cite its predicate K122894.
How does its category compare?
All NPM devicesNPM Bone Grafting Material, Animal Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NPM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPM
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPM
14in 2025
MAUDE reports naming product code NPM, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 3 | 112 | 0 | 0 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 4 | 349 | 0 | 1 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 5 | 191 | 0 | 3 |
| 2018 | 2 | — | 1 | 8 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 3 | 231 | 3 | 3 |
| 2021 | 2 | — | 0 | 4 |
| 2022 | 0 | — | 1 | 27 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 3 | 211 | 0 | 5 |
| 2025 | 3 | 30 | 0 | 14 |
| 2026 | 3 | 269 | 0 | — |
What is it indicated for?
Geistlich Bio-Flow@ is intended for bone regeneration of contained defects around teeth or dental implants for the following uses:
1. filling of extraction sockets to enhance preservation of the alveolar ridge in contained situations with entirely intact, circumferential bone walls.
2. filling of contained periodontal defects of limited size with intact lingual and buccal walls, i.e. 3-wall intrabony defects.
3. filling of contained peri-implant defects of limited size to include 3-wall defects of a size up to 4 mm x 5 mm x 4 mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242510: Geistlich Bio-Flow®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242510
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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