# K020664: Sterisharp 3-Gallon RSDC, Model RSDC3G

- Pathway: 510(k) (Traditional)
- Applicant: Sterilogic Waste Systems, Inc.
- Decided: May 14, 2002 after 74 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: 2 generations back to K964387 (1997). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931664: Sharps Disposable Containers, Bemis Mfg. Co. (1994) Summary page 1.
- K991612: Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5G, Sterilogic Waste Systems, Inc. (1999). Our OCR of the scanned summary read K991662, FDA’s number for Titanium Hartshill System (Surgicraft, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SteriSharp 2.5-Gallon RSDC”.

## Most influential descendants
- K083511: Enviro Sharp Solutions 3 (2009), 1 descendant of its own
- K131087: Sharpstank Reusable Sharps Container (2013), 0 descendants of its own
- K081821: D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip) (2008), 0 descendants of its own

## Indications for use
The SteriSharp™ 3-Gallon RSDC reusable containers are intended for use by healthcare providers (hospitals, laboratories, medical clinics, veterinary clinics, and other such areas and facilities where needles, sharps waste and other infectious waste is generated). The containers are designed to safely contain sharps waste prior to removal from generating facility and until ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse.

Source page: https://510kreport.com/device/K020664
Methodology: https://510kreport.com/methodology