# K240355: FROG  (Filter Removal of Glass)

- Pathway: 510(k) (Traditional)
- Applicant: Carrtech Corp
- Decided: Apr 18, 2025 after 438 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931367 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021475: BD Single Lumen Needle, Syringe and Blood Collection Set, Bd (2002) Summary page 6.

## Indications for use
The FROG device is a hypodermic needle and filter combination intended for use with syringes for general purpose fluid injection/aspiration and filtering. The FROG removabile filter allows the device to first withdraw medications from glass ampules and filter out glass fragments prior to subsequent administration after the removal of the filter cover. The FROG device is intended to be used by health care practitioners supporting medical care of any patient where delivery of drug housed in a glass primary container (where there is potential for glass particulate to get into drug upon opening of said primary container) is required.

Source page: https://510kreport.com/device/K240355
Methodology: https://510kreport.com/methodology