510(k) · Cleared
ClearedBec Shrouded Plastic Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biological & Environmental Control Laboratories · FMI Needle, Hypodermic, Single Lumen
Cleared on May 30, 1996 as substantially equivalent to K952834 (Medical Associates Network, Inc., 1995) and 1 other predicate after a 52-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- May 30, 1996
- Review
- 52 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945070 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK945070 Versasae Plastic Cannula- 11 GaugeImed Corp. · 1995 · Recalled
- This deviceK961328 Bec Shrouded Plastic CannulaBiological & Environmental Control Laboratories · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945070 | Versasae Plastic Cannula- 11 Gauge | Imed Corp. | 1995 | 1 |
| 0 (this device) | K961328 | Bec Shrouded Plastic Cannula | Biological & Environmental Control Laboratories | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (2)
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 |
|---|---|---|---|
| * | K952834 | Shrouded Plastic CannulaSummary page 1…the need of a sharp needle. This Shrouded Plastic Cannula is identical to Medical Network Associates, Incorporated's Shrouded Plastic Cannula reviewed by FDA in 510(k) #K952834 which was identical to and found to be substantially equivalent to IMED Corporations Shrouded Plastic Cannula submitted under 510… | 1995 |
| * | K945070 | Versasae Plastic Cannula- 11 GaugeSummary page 1…reviewed by FDA in 510(k) #K952834 which was identical to and found to be substantially equivalent to IMED Corporations Shrouded Plastic Cannula submitted under 510(k) #K945070. These cannulas are made of the same material by the same foreign manufacturer. Technological data and performance data were subm… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 1 of the 2 ancestors has a recall of any class.
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 Shrouded Plastic Cannula is intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the administration of fluids and medications. The Shrouded Plastic Cannula provides the ability to penetrate a split septum injection site or Y-site for entry into a intravascular system without the need of a sharp needle.
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/K961328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961328: Bec Shrouded Plastic Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961328
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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