# K233265: Monotime and Optime R

- Pathway: 510(k) (Abbreviated)
- Applicant: Peters Surgical
- Decided: Oct 11, 2024 after 378 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- 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 K944110 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031286: Safil and Safil Quick Synthetic Absorbable Surgical Suture, Aesculap, Inc. (2003) Summary page 5.

## Indications for use
OPTIME® R sutures are intended for use in general soft tissue approximation including ophthalmic procedures, but not in cardiovascular or neurological procedures.

Source page: https://510kreport.com/device/K233265
Methodology: https://510kreport.com/methodology