510(k) · Cleared
Recalled · 2010Surgical Sealant Dispenser (SSD)
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 Mar 25, 1988 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled once.
- Decided
- Mar 25, 1988
- Review
- 15 days
- Class
- Class I
- Product code
- KYZ
- Recalls
- 1
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK881020 Surgical Sealant Dispenser (SSD)Micromedics, Inc. · 1988
- Descendant · cites it directly · 8 of its ownK964833 Rmi Dual Fluid Irrigating SyringeResearch Medical, Inc. · 1997
- Descendant · cites it directly · 7 of its ownK973510 Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)Immuno-U.S., Inc. · 1997
- Descendant · 2 generations on · 3 of its ownK981089 Tissomat and Spray SetBaxter Healthcare Corp · 2000
- Descendant · 2 generations on · 1 of its ownK020666 Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter Healthcare Corp · 2002 · Recalled
- Descendant · 3 generations on · 0 of its ownK071126 Cryoseal FS Applicator SystemThermogenesis Corp. · 2007
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K964833Rmi Dual Fluid Irrigating SyringeResearch Medical, Inc. · 1997 · cites it directly8descendants
- K973510Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)Immuno-U.S., Inc. · 1997 · cites it directly7descendants
- K981089Tissomat and Spray SetBaxter Healthcare Corp · 2000 · 2 generations on3descendants
- K020666Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter Healthcare Corp · 2002 · 2 generations on1descendant
- K071126Cryoseal FS Applicator SystemThermogenesis Corp. · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K881020 | Surgical Sealant Dispenser (SSD) | Micromedics, Inc. | 1988 | — |
| +1 | K964833 | Rmi Dual Fluid Irrigating Syringe | Research Medical, Inc. | 1997 | — |
| +1 | K973510 | Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML) | Immuno-U.S., Inc. | 1997 | — |
| +2 | K981089 | Tissomat and Spray Set | Baxter Healthcare Corp | 2000 | — |
| +2 | K020666 | Duploject Easy-Prep System 1ML, 2ML, 5ML | Baxter Healthcare Corp | 2002 | 1 |
| +3 | K071126 | Cryoseal FS Applicator System | Thermogenesis Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 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? (9)
3 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-0346-2011 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K964833 (Research Medical, Inc., 1997) has gone furthest, with 8 descendants 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/K881020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K881020: Surgical Sealant Dispenser (SSD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881020
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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