# K984101: Flexiblade

- Pathway: 510(k) (Traditional)
- Applicant: Arco Medic, Ltd.
- Decided: Sep 3, 1999 after 290 days
- Product code: CCW (Laryngoscope, Rigid)
- Device class: 1
- Regulation: 21 CFR 868.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K831981 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831981: Laryngescope, W.E. Leder Enterprises, Inc. (1983) Summary page 2.
- K883414: Laryngoscope Blades, Truphatek, Ltd. (1988) Summary page 2.

## Indications for use
The Flexiblade™ - Flexible Laryngoscope is. intended for use as an aid for placement of tracheal tube and examination and vjsualization of patient’s upper airway.

Source page: https://510kreport.com/device/K984101
Methodology: https://510kreport.com/methodology