# K042285: Unicryl M

- Pathway: 510(k) (Traditional)
- Applicant: United Medical Industries Co., Ltd.
- Decided: Dec 10, 2004 after 108 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K081001: PD Synth, Absorbable (Poly Dioxanone) Suture (2008), 1 descendant of its own
- K161737: RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed (2017), 0 descendants of its own

## Indications for use
UniCryl M is indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery but not for use in cardiovascular, neurological procedures, or microsurgery.

Source page: https://510kreport.com/device/K042285
Methodology: https://510kreport.com/methodology