# K991612: Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5G

- Pathway: 510(k) (Traditional)
- Applicant: Sterilogic Waste Systems, Inc.
- Decided: May 28, 1999 after 18 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 K964387 (1997). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964387: Point of Use II Sharps-a-Gator, Graphic Controls Corp. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K964026: STP System - Saf, Sage Products, Inc. (1996). Our OCR of the scanned summary read K964026, FDA’s number for STP System - Saf (Sage Products, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Rotonics Manufacturing, Inc. (RMI) Rotationally Molded Plastic…”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K020664: Sterisharp 3-Gallon RSDC, Model RSDC3G (2002), 3 descendants of its own
- 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™ 2.5 Gallon RSDC reusable containers are intended to be used 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 ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse according to 49 CFR Sections 178.603, 173.4465(d), 173.465(e) and 178.608.

Source page: https://510kreport.com/device/K991612
Methodology: https://510kreport.com/methodology