510(k) · Cleared
ClearedSharpsaway II Locking Disposable Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jul 12, 2004 as substantially equivalent to K946289 (Devon Industries, Inc., 1995) after a 70-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Jul 12, 2004
- Review
- 70 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946289 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK946289 Devons Point Lok Needle Protection DeviceDevon Industries, Inc. · 1995
- This deviceK041153 Sharpsaway II Locking Disposable CupArrow Intl., Inc. · 2004
- Descendant · cites it directly · 1 of its ownK070577 ON the GO SharpsMedport, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK081821 D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip)Global Pathogen Solutions, Inc. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946289 | Devons Point Lok Needle Protection Device | Devon Industries, Inc. | 1995 | — |
| 0 (this device) | K041153 | Sharpsaway II Locking Disposable Cup | Arrow Intl., Inc. | 2004 | — |
| +1 | K070577 | ON the GO Sharps | Medport, Inc. | 2007 | — |
| +2 | K081821 | D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip) | Global Pathogen Solutions, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K946289 | Devons Point Lok Needle Protection DeviceSummary page 1…ssification Needle, Hypodermic, Single Lumen name: Legally marketed devices Devon Industries - Point-Lok® Neeedle Protection Device to which the device is (K946289) substantially equivalent: Description of device: The proposed SharpsAway IFTM Locking Disposal Cup was… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070577 | ON the GO Sharps | 2007 | 1 |
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 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 Arrow SharpsAway IITM Locking Disposal Cup is intended as a single use needle protection
device, which covers the end of needles after use to minimize the risk of needle sticks. This
device is designed for use with 15 Ga. to 30 Ga. needles for various clinical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041153: Sharpsaway II Locking Disposable Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041153
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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