510(k) · Cleared
ClearedNAR Sharps Shuttle; NAR Sharps Shuttle Pack of six
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North American Rescue, LLC · MMK Container, Sharps
Cleared on May 31, 2016 as substantially equivalent to K972279 (Sage Products, Inc., 1997) after a 286-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- May 31, 2016
- Review
- 286 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972279 (1997). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK972279 Sharps ShuttleSage Products, Inc. · 1997
- This deviceK152340 NAR Sharps Shuttle; NAR Sharps Shuttle Pack of sixNorth American Rescue, LLC · 2016
- Descendant · cites it directly · 2 of its ownK211464 Nitta M&T Safety BoxNitta M&T (Thailand) Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK222905 Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon…Ningbo Maxcon Medical Technology Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK253222 Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K211464Nitta M&T Safety BoxNitta M&T (Thailand) Co., Ltd. · 2021 · cites it directly2descendants
- K222905Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT…Ningbo Maxcon Medical Technology Co., Ltd. · 2023 · 2 generations on1descendant
- K253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972279 | Sharps Shuttle | Sage Products, Inc. | 1997 | — |
| 0 (this device) | K152340 | NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six | North American Rescue, LLC | 2016 | — |
| +1 | K211464 | Nitta M&T Safety Box | Nitta M&T (Thailand) Co., Ltd. | 2021 | — |
| +2 | K222905 | Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps… | Ningbo Maxcon Medical Technology Co., Ltd. | 2023 | — |
| +3 | 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 |
|---|---|---|
| 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 MMK? 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 MMK device
- #1 K253773 Guanhong Sharps Container (GHW-1F1); Guanhong…score 12.3 · 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? (1)
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 |
|---|---|---|---|
| * | K972279 | Sharps ShuttleSummary page 4…Common Name Container Sharps Code –Name –Classification MMK – Hypodermic single lumen needle - 21 CFR 880.5570: Class II Predicate Devices Sage Sharps Shuttle K972279 (ownership acquired by Tyco/now Covidien) Device Description Device Description: The North American Rescue Sharps Shuttl… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211464 | Nitta M&T Safety Box | 2021 | 2 |
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?
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MMK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMK
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MMK
No recall names MMK since 2007.
Adverse event reports per year · MMK
5in 2025
MAUDE reports naming product code MMK, 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 | 4 | 63 | 0 | 5 |
| 2008 | 6 | 61 | 0 | 21 |
| 2009 | 4 | 100 | 0 | 9 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 2 | — | 0 | 16 |
| 2013 | 5 | 136 | 0 | 20 |
| 2014 | 6 | 210 | 0 | 13 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 4 | 258 | 0 | 27 |
| 2017 | 1 | — | 0 | 39 |
| 2018 | 1 | — | 0 | 63 |
| 2019 | 4 | 265 | 0 | 56 |
| 2020 | 1 | — | 0 | 62 |
| 2021 | 3 | 149 | 0 | 85 |
| 2022 | 1 | — | 0 | 38 |
| 2023 | 3 | 251 | 0 | 34 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 3 | 84 | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The North American Rescue Sharps Shuttle is a molded polypropylene, non-sterile, single use, portable transportable
sharps container. Its permanent closure system protects the user prior to disposal via incineration.
The North American Rescue Sharps Shuttle is approximately 6.41” in length, with a sharps aperture of approximately 1”
in diameter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152340 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152340: NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152340
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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