510(k) · Cleared
ClearedCytoflex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unicare Biomedical, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on Oct 1, 2001 as substantially equivalent to K974752 (Imtec Corp., 1998) and 3 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Oct 1, 2001
- Review
- 83 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K922627 (1994). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK922627 Gore-Tex Regenerative MaterialW. L. Gore & Associates, Inc. · 1994
- 1 generation backK964342 Cytoplast GBROsteogenics Co. · 1997
- This deviceK012144 CytoflexUnicare Biomedical, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK160493 Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg…Salvin Dental Specialties · 2016
- Descendant · 2 generations on · 0 of its ownK222549 OpenTexPurgo Biologics, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922627 | Gore-Tex Regenerative Material | W. L. Gore & Associates, Inc. | 1994 | — |
| −1 | K964342 | Cytoplast GBR | Osteogenics Co. | 1997 | — |
| 0 (this device) | K012144 | Cytoflex | Unicare Biomedical, Inc. | 2001 | — |
| +1 | K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable… | Salvin Dental Specialties | 2016 | — |
| +2 | K222549 | OpenTex | Purgo Biologics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2023 | 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 LYC? 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 LYC device
- #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K974752 | Imtec/Biobarrier MembraneSummary page 1…brane Classification Name: Implant, Endosseous for bone filling and/or augmentation Device Classification: Unclassified 3. Predicate Devices Imtec BioBarrier membrane (K974752; Imtec Corporation) Osteogenics Cytoplast GBR (K964342; Osteogenics Corporation) Gore-tex Regenerative Material (K922627; W.L. Go… | 1998 |
| * | K964342 | Cytoplast GBRSummary page 1…filling and/or augmentation Device Classification: Unclassified 3. Predicate Devices Imtec BioBarrier membrane (K974752; Imtec Corporation) Osteogenics Cytoplast GBR (K964342; Osteogenics Corporation) Gore-tex Regenerative Material (K922627; W.L. Gore & Associates, Inc.) TefGen-FD (K935137; American Cus… | 1997 |
| * | K922627 | Gore-Tex Regenerative MaterialSummary page 1…3. Predicate Devices Imtec BioBarrier membrane (K974752; Imtec Corporation) Osteogenics Cytoplast GBR (K964342; Osteogenics Corporation) Gore-tex Regenerative Material (K922627; W.L. Gore & Associates, Inc.) TefGen-FD (K935137; American Custom Medical) 4. Device Description CytoFlex™ is a non-resorbable… | 1994 |
| * | K935137 | Tefgen-FDSummary page 1…974752; Imtec Corporation) Osteogenics Cytoplast GBR (K964342; Osteogenics Corporation) Gore-tex Regenerative Material (K922627; W.L. Gore & Associates, Inc.) TefGen-FD (K935137; American Custom Medical) 4. Device Description CytoFlex™ is a non-resorbable barrier membrane that is composed of microporous… | 1994 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE… | 2016 | 1 |
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 7 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K160493 (Salvin Dental Specialties, 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K974752.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYC
2in 2025
MAUDE reports naming product code LYC, 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 | 13 | 80 | 0 | 23 |
| 2008 | 8 | 73 | 0 | 25 |
| 2009 | 14 | 100 | 1 | 25 |
| 2010 | 13 | 164 | 2 | 28 |
| 2011 | 9 | 224 | 0 | 21 |
| 2012 | 5 | 120 | 2 | 10 |
| 2013 | 2 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 2 | 140 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 14 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 3 | 156 | 0 | 5 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 3 | 267 | 0 | 2 |
| 2026 | 3 | 266 | 0 | — |
What is it indicated for?
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012144: Cytoflex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012144
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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