# K921822: Fray Bio-Punch

- Pathway: 510(k) (Traditional)
- Applicant: Fray Products Corp.
- Decided: Oct 28, 1992 after 195 days
- Product code: MDM (Instrument, Manual, Surgical, General Use)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: 3 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Mar 18, 2013 · Class II · Z-1654-2013: Due to lack of sterilization.
- Mar 18, 2013 · Class II · Z-1655-2013: Due to lack of sterilization.
- Mar 18, 2013 · Class II · Z-1656-2013: Due to lack of sterilization.

Source page: https://510kreport.com/device/K921822
Methodology: https://510kreport.com/methodology