510(k) · Cleared
ClearedB-D Guardian Nestable Sharps Collectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · FMI Needle, Hypodermic, Single Lumen
Cleared on Oct 14, 1994 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Oct 14, 1994
- Review
- 84 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 5 citing it directly.
- This deviceK943575 B-D Guardian Nestable Sharps CollectorsBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
- Descendant · cites it directly · 7 of its ownK130281 Oak Ridge Products Sharp ContainerOak Ridge Products, LLC · 2013
- Descendant · cites it directly · 4 of its ownK072667 Sharps Away Disposable ContainerSolutions, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK161180 Oak Ridge Products Sharps ContainersOak Ridge Products, LLC · 2016
- Descendant · 3 generations on · 2 of its ownK180984 Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK131708 Bwcsh-1 Sharps ContainerBradford Wright Companies, Inc. · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K130281Oak Ridge Products Sharp ContainerOak Ridge Products, LLC · 2013 · cites it directly7descendants
- K072667Sharps Away Disposable ContainerSolutions, Inc. · 2007 · cites it directly4descendants
- K161180Oak Ridge Products Sharps ContainersOak Ridge Products, LLC · 2016 · 2 generations on3descendants
- K180984Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd. · 2019 · 3 generations on2descendants
- K131708Bwcsh-1 Sharps ContainerBradford Wright Companies, Inc. · 2014 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943575 | B-D Guardian Nestable Sharps Collectors | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | — |
| +1 | K130281 | Oak Ridge Products Sharp Container | Oak Ridge Products, LLC | 2013 | — |
| +1 | K072667 | Sharps Away Disposable Container | Solutions, Inc. | 2007 | — |
| +2 | K161180 | Oak Ridge Products Sharps Containers | Oak Ridge Products, LLC | 2016 | — |
| +3 | K180984 | Maxcon Sharps Container | Ningbo Maxcon Medical Technology Co., Ltd. | 2019 | — |
| +1 | K131708 | Bwcsh-1 Sharps Container | Bradford Wright Companies, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 165 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, K130281 (Oak Ridge Products, LLC, 2013) has gone furthest, with 7 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) | — |
https://510kreport.com/device/K943575 · printed Nov 4, 2026
Cite this page
510(k) Report. “K943575: B-D Guardian Nestable Sharps Collectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K943575
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026