510(k) · Cleared
ClearedBio-Plexus Drop-IT Needle Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Plexus, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jun 6, 1997 after a 262-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jun 6, 1997
- Review
- 262 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK963748 Bio-Plexus Drop-IT Needle HolderBio-Plexus, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK980098 Vacutainer Brand Pronto Needles HolderBecton Dickinson Vacutainer Systems · 1998
- Descendant · 2 generations on · 0 of its ownK032141 Secumax Blood Collection SystemTiger Meditech Incorporated · 2004
- Descendant · cites it directly · 0 of its ownK992091 Punctur-Guard Revolution Holder, Model 4750Bio-Plexus, Inc. · 1999
Most influential descendants
Showing 3 of 3 · See all- K980098Vacutainer Brand Pronto Needles HolderBecton Dickinson Vacutainer Systems · 1998 · cites it directly1descendant
- K032141Secumax Blood Collection SystemTiger Meditech Incorporated · 2004 · 2 generations on0descendants
- K992091Punctur-Guard Revolution Holder, Model 4750Bio-Plexus, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963748 | Bio-Plexus Drop-IT Needle Holder | Bio-Plexus, Inc. | 1997 | — |
| +1 | K980098 | Vacutainer Brand Pronto Needles Holder | Becton Dickinson Vacutainer Systems | 1998 | — |
| +2 | K032141 | Secumax Blood Collection System | Tiger Meditech Incorporated | 2004 | — |
| +1 | K992091 | Punctur-Guard Revolution Holder, Model 4750 | Bio-Plexus, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | — | Vacutainer® Brand Needle Holder #4893 Named without a submission number | |
| * | — | Sage Products AutoDrop® Needle Holder #1510 Named without a submission number |
What descends from it? (3)
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, K980098 (Becton Dickinson Vacutainer Systems, 1998) has gone furthest, with 1 descendant 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) | — |
What is it indicated for?
The Bio-Plexus DROP-IT® Needle Holder is a venipuncture needle holder which is recommended for use with standard blood collection needles including the PUNCTUR-GUARD® Blood Collection Needle as well as PUNCTUR-GUARD® Winged Sets for Blood Collection. It also mates with the Bio-Plexus Needle Disposal Container for easy needle diqusal. This is a non-sterile reusable device recommended for a maximum of 100 uses.
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/K963748 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963748: Bio-Plexus Drop-IT Needle Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963748
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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