# K972279: Sharps Shuttle

- Pathway: 510(k) (Traditional)
- Applicant: Sage Products, Inc.
- Decided: Aug 29, 1997 after 72 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- 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
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BD Home Sharps Container: named in the summary without a submission number
- (no number) One Quart Sharps Container: named in the summary without a submission number
- (no number) Sharp-Safe: named in the summary without a submission number
- (no number) Stic-Kit: named in the summary without a submission number

## Most influential descendants
- K152340: NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six (2016), 3 descendants of its own
- K211464: Nitta M&T Safety Box (2021), 2 descendants of its own
- K222905: Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) (2023), 1 descendant of its own
- K990936: The Vault (1999), 1 descendant of its own
- K253222: Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) (2025), 0 descendants of its own

## Indications for use
The Sharps Shuttle and Sharp Shuttle with Locking Mechanism are single use, non-sterile, disposable, sharps transport containers intended for use in any setting where standard sharps containers are not conveniently accessible, such as EMS, home health care, etc..

Source page: https://510kreport.com/device/K972279
Methodology: https://510kreport.com/methodology