# K130281: Oak Ridge Products Sharp Container

- Pathway: 510(k) (Abbreviated)
- Applicant: Oak Ridge Products, LLC
- Decided: Jun 21, 2013 after 136 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 K943575 (1994). 3 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943575: B-D Guardian Nestable Sharps Collectors, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 2.
- K943659: Ancillary and Large Volume Sharps Disposal Containers, Sage Products, Inc. (1995) Summary page 2.
- K943660: Phlebotomy Sharps Disposal Containers, Sage Products, Inc. (1995) Summary page 2.

## Most influential descendants
- K161180: Oak Ridge Products Sharps Containers (2016), 3 descendants of its own
- K180984: Maxcon Sharps Container (2019), 2 descendants of its own
- K253773: Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong (2026), 0 descendants of its own
- K253222: Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) (2025), 0 descendants of its own
- K231484: PureWay 1.4 Quart Sharps Collector (2023), 0 descendants of its own

## Indications for use
Oak Ridge Products Sharps containers are single-use, disposable, non-sterile containers intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for trained healthcare professionals. The 1 quart Phlebotomy container is intended to be used with an appropriate mounting device. The 5.4 quart is intended to be used with an appropriate mounting device. The 2 gallon container is intended to be used in areas where there is no unsupervised patient access.

Source page: https://510kreport.com/device/K130281
Methodology: https://510kreport.com/methodology