# K924273: Accuflate

- Pathway: 510(k) (Traditional)
- Applicant: Instrumed, Inc.
- Decided: Jan 12, 1993 after 141 days
- Product code: KCY (Tourniquet, Pneumatic)
- Device class: 1
- Regulation: 21 CFR 878.5910
- 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
- Apr 13, 2010 · Not classified · Z-0914-2011: This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time t
- Apr 13, 2010 · Not classified · Z-0912-2011: This recall is related to the Electi-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time th
- Apr 13, 2010 · Not classified · Z-0913-2011: This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time t

Source page: https://510kreport.com/device/K924273
Methodology: https://510kreport.com/methodology