# K881020: Surgical Sealant Dispenser (SSD)

- Pathway: 510(k) (Traditional)
- Applicant: Micromedics, Inc.
- Decided: Mar 25, 1988 after 15 days
- Product code: KYZ (Syringe, Irrigating (Non Dental))
- Device class: 1
- Regulation: 21 CFR 880.6960
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964833: Rmi Dual Fluid Irrigating Syringe (1997), 8 descendants of its own
- K973510: Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML) (1997), 7 descendants of its own
- K981089: Tissomat and Spray Set (2000), 3 descendants of its own
- K020666: Duploject Easy-Prep System 1ML, 2ML, 5ML (2002), 1 descendant of its own
- K071126: Cryoseal FS Applicator System (2007), 0 descendants of its own

## Recalls of this device
- Mar 15, 2010 · Not classified · Z-0346-2011: 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 trans

Source page: https://510kreport.com/device/K881020
Methodology: https://510kreport.com/methodology