# K091690: Sharp Chute

- Pathway: 510(k) (Traditional)
- Applicant: Heathrow Scientific, LLC
- Decided: Jul 28, 2009 after 48 days
- Product code: MMK (Container, Sharps)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K943892 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943139: B-D Guardian One Piece Sharps Collectors, Med-Safe Systems, Inc. (1994) Summary page 1.
- K990936: The Vault, Stik Stoppers, Inc. (1999) Summary page 1.
- K980490: Sage Products Inc, Sharps Disposal Containers with Screw Top Caps, Sage Products, Inc. (1998) Summary page 1.
- K964387: Point of Use II Sharps-a-Gator, Graphic Controls Corp. (1997) Summary page 1.

## Indications for use
The Sharp Chute TM is an over-the-counter, single-use, disposable, non-sterile sharps container intended to be used with medical sharps including, but not limited to, hypodermic needles, syringes, lancets, and blood needles. The containers can be used in any area requiring sharps collection prior to their final disposal. When the container is filled to the max-capacity indicator, it is intended to be permanently locked and ultimately disposed of.

Source page: https://510kreport.com/device/K091690
Methodology: https://510kreport.com/methodology