PMA · Approved
Recalled · Class II · 2023Coseal Surgical Sealant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Bio Science · NBE Sealant, Polymerizing
Approved on Dec 12, 2003 through premarket approval, which rests on the device’s own clinical evidence after a 149-day review. It has been recalled 6 times.
- Decided
- Dec 12, 2003
- Review
- 149 days
- Class
- Class III
- Product code
- NBE
- Recalls
- 6
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P030039 has 28 supplements since 2004: 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 |
|---|---|
| 2004 | 1 |
| 2006 | 2 |
| 2007 | 4 |
| 2008 | 4 |
| 2009 | 2 |
| 2010 | 2 |
| 2015 | 1 |
| 2018 | 4 |
| 2020 | 2 |
| 2021 | 2 |
| 2023 | 1 |
| 2025 | 3 |
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 NBE? 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 |
|---|---|---|---|---|
| Dec 6, 2023 | Class II | Z-0657-2024 | Under Investigation by firm | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information… |
| May 12, 2016 | Class II | Z-1838-2016 | Nonconforming Material/Component | Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use. |
| Jul 28, 2011 | Not classified | Z-1614-2012 | Device Design | The recall is being conducted as a precautionary measure due to out of specification results observed at the 24 months time point (out of 24-month licensed shelf life to expiration) during a Coseal stability study. The parameter that is… |
| Jan 14, 2010 | Not classified | Z-1950-2010 | Process control | The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to expiration) for the percent thiol substitution during a… |
| Jan 14, 2010 | Not classified | Z-1949-2010 | Process control | The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to expiration) for the percent thiol substitution during a… |
| Jan 14, 2010 | Not classified | Z-1948-2010 | Process control | The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to expiration) for the percent thiol substitution during a… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NBE devicesNBE Sealant, Polymerizing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NBE
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBE
Too few NBE 510(k)s in any year since 2007 to give a median.
Recalls per year · NBE
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NBE
15in 2025
MAUDE reports naming product code NBE, 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 | 4 | — | 0 | 25 |
| 2008 | 4 | — | 0 | 20 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 10 | — | 3 | 7 |
| 2011 | 6 | — | 1 | 9 |
| 2012 | 12 | — | 0 | 9 |
| 2013 | 10 | — | 0 | 4 |
| 2014 | 4 | — | 0 | 12 |
| 2015 | 7 | — | 0 | 10 |
| 2016 | 8 | — | 0 | 44 |
| 2017 | 13 | — | 0 | 12 |
| 2018 | 23 | — | 0 | 10 |
| 2019 | 2 | — | 0 | 7 |
| 2020 | 5 | — | 0 | 27 |
| 2021 | 11 | — | 0 | 9 |
| 2022 | 3 | — | 0 | 12 |
| 2023 | 5 | — | 2 | 14 |
| 2024 | 3 | — | 0 | 24 |
| 2025 | 11 | — | 0 | 15 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/P030039 · printed Nov 4, 2026
Cite this page
510(k) Report. “P030039: Coseal Surgical Sealant.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P030039
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026