510(k) · Cleared
ClearedSharps Shuttle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sage Products, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Aug 29, 1997 after a 72-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Aug 29, 1997
- Review
- 72 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK972279 Sharps ShuttleSage Products, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK152340 NAR Sharps Shuttle; NAR Sharps Shuttle Pack of sixNorth American Rescue, LLC · 2016
- Descendant · 2 generations on · 2 of its ownK211464 Nitta M&T Safety BoxNitta M&T (Thailand) Co., Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK222905 Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon…Ningbo Maxcon Medical Technology Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK990936 The VaultStik Stoppers, Inc. · 1999
- Descendant · 4 generations on · 0 of its ownK253222 Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K152340NAR Sharps Shuttle; NAR Sharps Shuttle Pack of sixNorth American Rescue, LLC · 2016 · cites it directly3descendants
- K211464Nitta M&T Safety BoxNitta M&T (Thailand) Co., Ltd. · 2021 · 2 generations on2descendants
- K222905Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT…Ningbo Maxcon Medical Technology Co., Ltd. · 2023 · 3 generations on1descendant
- K990936The VaultStik Stoppers, Inc. · 1999 · cites it directly1descendant
- K253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972279 | Sharps Shuttle | Sage Products, Inc. | 1997 | — |
| +1 | K152340 | NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six | North American Rescue, LLC | 2016 | — |
| +2 | K211464 | Nitta M&T Safety Box | Nitta M&T (Thailand) Co., Ltd. | 2021 | — |
| +3 | K222905 | Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps… | Ningbo Maxcon Medical Technology Co., Ltd. | 2023 | — |
| +1 | K990936 | The Vault | Stik Stoppers, Inc. | 1999 | — |
| +4 | K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | Zhejiang Gongdong Medical Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FMI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | BD Home Sharps Container Named without a submission number | |
| * | — | One Quart Sharps Container Named without a submission number | |
| * | — | Sharp-Safe Named without a submission number | |
| * | — | Stic-Kit Named without a submission number |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K152340 (North American Rescue, LLC, 2016) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
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..
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972279 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972279: Sharps Shuttle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972279
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026