510(k) · Cleared
ClearedUltratine Transbleph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coapt Systems, Inc. · HWC Screw, Fixation, Bone
Cleared on Jun 12, 2006 as substantially equivalent to K040740 (Coapt Systems, Inc., 2004) and 1 other predicate after a 132-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Jun 12, 2006
- Review
- 132 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K014153 (2002). 6 ancestors in all, the oldest K944110 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 3 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 2 generations backK033524 Coapt Endotine Chin 3.5 DeviceCoapt Systems, Inc. · 2003
- 1 generation backK040740 Endotine Transbleph DeviceCoapt Systems, Inc. · 2004
- This deviceK060248 Ultratine TransblephCoapt Systems, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −3 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −2 | K033524 | Coapt Endotine Chin 3.5 Device | Coapt Systems, Inc. | 2003 | — |
| −1 | K040740 | Endotine Transbleph Device | Coapt Systems, Inc. | 2004 | — |
| 0 (this device) | K060248 | Ultratine Transbleph | Coapt Systems, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 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? (2)
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 |
|---|---|---|---|
| * | K040740 | Endotine Transbleph DeviceSummary page 2…PMA Nunin ENDOTINE TransBlephTM HWC Coapt Systems, Inc K040740 Vicryl GAM Ethicon K944110 DEVICE DESCRIPTION The ULTRATINE TransBlep… | 2004 |
| * | K944110 | Vicryl Rapide SutureSummary page 2…Nunin ENDOTINE TransBlephTM HWC Coapt Systems, Inc K040740 Vicryl GAM Ethicon K944110 DEVICE DESCRIPTION The ULTRATINE TransBleph TM consists of a bioabsorbable implant. This device is supplied sterile for single u… | 1995 |
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 4 years and passes through 1 company; a new generation was cleared every 12 months on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K040740.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The ULTRATINE TransBleph TM is intended for use in subperiosteal browplasty fixation. The ULTRATINE TransBleph is specifically indicated for use to fixate the subdermis to the frontal bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060248: Ultratine Transbleph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060248
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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