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
Med-Safe Systems, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Nov 7, 1994 after a 131-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Nov 7, 1994
- Review
- 131 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK943134 B-D Guardian Nestable Sharps CollectorsMed-Safe Systems, Inc. · 1994
- Descendant · cites it directly · 3 of its ownK112774 BD Recykleen Sharps CollectorsBecton, Dickinson and Company · 2012
- Descendant · 2 generations on · 2 of its ownK132476 Sharps ContainerGrp & Associates · 2014
- Descendant · 3 generations on · 1 of its ownK151249 Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2…Pureway Compliance, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK140285 B Travelsavvy Sharps ContainerBellegrove Medical Supply, Inc. · 2014
- Descendant · 4 generations on · 0 of its ownK251874 PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K112774BD Recykleen Sharps CollectorsBecton, Dickinson and Company · 2012 · cites it directly3descendants
- K132476Sharps ContainerGrp & Associates · 2014 · 2 generations on2descendants
- K151249Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon, Pureway Sharps…Pureway Compliance, Inc. · 2015 · 3 generations on1descendant
- K140285B Travelsavvy Sharps ContainerBellegrove Medical Supply, Inc. · 2014 · cites it directly1descendant
- K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc. · 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) | K943134 | B-D Guardian Nestable Sharps Collectors | Med-Safe Systems, Inc. | 1994 | — |
| +1 | K112774 | BD Recykleen Sharps Collectors | Becton, Dickinson and Company | 2012 | — |
| +2 | K132476 | Sharps Container | Grp & Associates | 2014 | — |
| +3 | K151249 | Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon… | Pureway Compliance, Inc. | 2015 | — |
| +1 | K140285 | B Travelsavvy Sharps Container | Bellegrove Medical Supply, Inc. | 2014 | — |
| +4 | K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) | Pureway Compliance, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2025 | 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? (6)
2 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, K112774 (Becton, Dickinson and Company, 2012) 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) | — |
https://510kreport.com/device/K943134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943134: B-D Guardian Nestable Sharps Collectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943134
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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