# K955282: Thermogenesis Drop Applicator, Kits, Spray Kits and Tips

- Pathway: 510(k) (Traditional)
- Applicant: Thermogenesis Corp.
- Decided: May 6, 1996 after 172 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Liquid medication dispenser distributed by Hemaedics: named in the summary without a submission number
- (no number) Liquid medication dispenser distributed by Micromedics: named in the summary without a submission number

## Indications for use
ThermoGenesis Applicators and Applicator Tips are intended to deliver two solutions simultaneously to a medical or surgical site This products are supplied sterile and are intended for single patient use. The ThermoGenesis Applicator product line consists of two devices: (1) a drop applicator with various straight, angled and flexible dual cannulated applicator tips, and (2) a spray application device with tip. All configurations of these products allow the user to deliver two solutions using one hand. All configurations of the devices are only intended for simultaneous application of two solutions and are specifically not intended for intravenous injection.

Source page: https://510kreport.com/device/K955282
Methodology: https://510kreport.com/methodology