510(k) · Cleared
Recalled · 2010Surgical Sealant Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micromedics, Inc. · KYZ Syringe, Irrigating (Non Dental)
Cleared on Aug 23, 1988 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 23, 1988
- Review
- 14 days
- Class
- Class I
- Product code
- KYZ
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK883338 Surgical Sealant ApplicatorMicromedics, Inc. · 1988
- Descendant · cites it directly · 1 of its ownK020147 Magellan Ratio Dispenser Kit/Magellan Spray Tip/Magellan Cannula TipMedtronic Perfusion Systems · 2002
- Descendant · cites it directly · 0 of its ownK091722 Coaxial Applicator SystemBiomet, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK041830 Magellan Ratio Dispenser KitMedtronic Perfusion Systems · 2004
Most influential descendants
Showing 3 of 3 · See all- K020147Magellan Ratio Dispenser Kit/Magellan Spray Tip/Magellan Cannula TipMedtronic Perfusion Systems · 2002 · cites it directly1descendant
- K091722Coaxial Applicator SystemBiomet, Inc. · 2010 · cites it directly0descendants
- K041830Magellan Ratio Dispenser KitMedtronic Perfusion Systems · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883338 | Surgical Sealant Applicator | Micromedics, Inc. | 1988 | — |
| +1 | K020147 | Magellan Ratio Dispenser Kit/Magellan Spray Tip/Magellan Cannula Tip | Medtronic Perfusion Systems | 2002 | — |
| +1 | K091722 | Coaxial Applicator System | Biomet, Inc. | 2010 | — |
| +2 | K041830 | Magellan Ratio Dispenser Kit | Medtronic Perfusion Systems | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KYZ? 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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2010 | Not classified | Z-0345-2011 | Packaging process control | Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection. |
| Nov 16, 2009 | Not classified | Z-1537-2012 | Labeling mix-ups | This product has been recalled due to the lot number being different on the box and pouch. The lot number on the box label was incorrectly printed as 11144 instead of 111144. The pouch label referenced the correct lot number, 111144. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K020147 (Medtronic Perfusion Systems, 2002) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KYZ devicesKYZ Syringe, Irrigating (Non Dental): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KYZ
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KYZ
Too few KYZ 510(k)s in any year since 2007 to give a median.
Recalls per year · KYZ
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KYZ
28in 2025
MAUDE reports naming product code KYZ, 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 | 0 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 1 | — | 1 | 3 |
| 2010 | 0 | — | 2 | 2 |
| 2011 | 1 | — | 1 | 4 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 11 |
| 2016 | 0 | — | 5 | 8 |
| 2017 | 0 | — | 0 | 52 |
| 2018 | 0 | — | 1 | 76 |
| 2019 | 0 | — | 0 | 69 |
| 2020 | 1 | — | 0 | 88 |
| 2021 | 0 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 1 (1) | 14 |
| 2024 | 0 | — | 0 | 106 |
| 2025 | 0 | — | 0 | 28 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K883338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K883338: Surgical Sealant Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883338
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026