510(k) · Cleared
ClearedNeedle Incapacitator (Needle Guard)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pdmp, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Dec 22, 2004 after a 62-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 22, 2004
- Review
- 62 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
NEEDLE GUARD is an individual self-contained point-of-use contaminated needle and syringe sharps management system that fully encapsulates the needle of a luer-lock syringe. The Needle Guard will accept any standard disposable syringe body or luer-lock needle. Standard syringe and needle luer-lock are defined as any syringe without a mechanical safety device attached. Needle Guard will accept any gauge needle and needles up to and including a length of…
Read the full statement (197 words)
NEEDLE GUARD is an individual self-contained point-of-use contaminated needle and syringe sharps management system that fully encapsulates the needle of a luer-lock syringe. The Needle Guard will accept any standard disposable syringe body or luer-lock needle. Standard syringe and needle luer-lock are defined as any syringe without a mechanical safety device attached. Needle Guard will accept any gauge needle and needles up to and including a length of one and one-half inches (1 1/2"). It is a one-handed procedure that is used immediately after the use of the syringe at point of procedure. The NEEDLE GUARD can be disposed of individually or once the tray is full, of encapsulated needles and syringes, into a large sharps container and/or red biohazard bag.
Needle Guards are prepackaged in a disposable plastic tray to be used when syringe is inserted into Needle Guard.
The device is for use by health care professionals in hospitals and private practices, research laboratories, specialized medicines applications, clinics, nursing homes, home care and a multitude of other applications, i.e., onsite emergency care, needle exchange programs, dental offices, veterinarians, mortuaries.
Caution: U.S.A. law restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042907 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042907: Needle Incapacitator (Needle Guard).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042907
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026