# K172719: HealthBeacon HB2 Sharps Bin

- Pathway: 510(k) (Traditional)
- Applicant: Healthbeacon, Ltd.
- Decided: May 11, 2018 after 245 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: 1 generation back to K132767 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132767: Medline Sharps Container, Medline Industries, Inc. (2014) Summary page 4.

## Indications for use
The HealthBeacon HB2 Sharps Bin is intended for use by a single patient in the home setting. The HealthBeacon HB2 Sharps Bin comprises an outer enclosure that remains in the home. The outer enclosure contains a replaceable, single-use sharps bin that is intended to provide a receptacle for used, contaminated medical sharps. The single-use sharps bin also acts as an enclosure during transport of the used sharps to ultimate disposal. The HealthBeacon HB2 Sharps Bin outer enclosure is a neutral gray color body with duck egg sides. The approximate dimensions are: width 9.5 inches by depth 9.4 inches and height 6.9 inches, with a weight of 5lb, including an empty sharps bin. The inner, single-use sharps bin has a yellow semi-translucent body with a blue lid. The approximate dimensions of the bin are: width 9 inches by depth 7 inches and height of 4.5 inches. The gross volume is 2.4 US quarts, with an empty weight of 110z The outer enclosure has a trap door to allow the used sharps to be deposited into the inner sharps bin. The aperture of the trap door, and thus the maximum size of a used sharp, is 6.5 by 1 inches.

Source page: https://510kreport.com/device/K172719
Methodology: https://510kreport.com/methodology