PMA · Approved
Recalled · Class II · 2021Bioglue Surgical Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryolife, Inc. · MUQ Glue, Surgical, Arteries
Approved on Dec 3, 2001 through premarket approval, which rests on the device’s own clinical evidence after a 304-day review. It has been recalled 4 times.
- Decided
- Dec 3, 2001
- Review
- 304 days
- Class
- Class III
- Product code
- MUQ
- Recalls
- 4
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P010003 has 40 supplements since 2002: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2002 | 2 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 3 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2016 | 5 |
| 2017 | 3 |
| 2018 | 3 |
| 2019 | 5 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 7, 2021 | Class II | Z-0384-2022 | No Marketing Application | Product is not approved for use in the EU and should not have been distributed in the EU. |
| Jun 4, 2018 | Class II | Z-2556-2018 | Error in labeling | The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes. |
| May 19, 2017 | Class II | Z-2623-2017 | Labeling mix-ups | The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002. |
| Apr 25, 2014 | Class II | Z-1674-2014 | Process control | Serum albumin component monomer failed to meet internally established end of shelf-life specification. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MUQ devicesMUQ Glue, Surgical, Arteries: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUQ
Too few MUQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MUQ
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUQ
11in 2025
MAUDE reports naming product code MUQ, 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 | 3 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 14 |
| 2010 | 1 | — | 0 | 50 |
| 2011 | 0 | — | 0 | 30 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 1 | — | 0 | 47 |
| 2014 | 0 | — | 0 | 40 |
| 2015 | 1 | — | 0 | 56 |
| 2016 | 5 | — | 0 | 28 |
| 2017 | 3 | — | 0 | 31 |
| 2018 | 3 | — | 0 | 25 |
| 2019 | 5 | — | 0 | 39 |
| 2020 | 0 | — | 0 | 25 |
| 2021 | 2 | — | 2 | 25 |
| 2022 | 1 | — | 0 | 12 |
| 2023 | 1 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 11 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/P010003 · printed Nov 6, 2026
Cite this page
510(k) Report. “P010003: Bioglue Surgical Adhesive.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P010003
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026