# K961853: Proline Fast Pass Arthoscopic Needle Passer

- Pathway: 510(k) (Traditional)
- Applicant: Acufex Microsurgical, Inc.
- Decided: Jun 21, 1996 after 38 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- P810028: Deklene (TM), Deknatel, Inc.. FDA lists this PMA only through its supplements; the earliest we hold is P810028/S001 (Jun 22, 1983). Summary page 1.
- (no number) Shutt Arthroscopic Suture Passer: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K830509: Emergency Tracheostomy & Cricothyroido-, Frederic J. Toye, M.D. (1983). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K850378: LDH Reagent for Demand Analyzer, Advanced Biomedical Methods, Inc. (1985). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K970416: Acufex Double Armed Suture Needle (1997), 0 descendants of its own

## Indications for use
The Fast Pass Suture Punch System is indicated for the placement of sutures in Rotator Cuff and Bankart repair procedures.

Source page: https://510kreport.com/device/K961853
Methodology: https://510kreport.com/methodology