510(k) · Cleared
ClearedNovaguard, Model 3611001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
West Pharmaceutical Services, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Apr 24, 2009 as substantially equivalent to K043397 (Becton, Dickinson & CO, 2004) and 3 other predicates after a 206-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Apr 24, 2009
- Review
- 206 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K904198 (1990). 13 ancestors in all, the oldest K771203 (1977). No later device cites it as a predicate yet.
- Root · 4 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 3 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 2 generations backK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
- 1 generation backK040531 Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004
- This deviceK082908 Novaguard, Model 3611001West Pharmaceutical Services, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −3 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| −2 | K031453 | Terumo Surguard 2 Safety Needle | Terumo Medical Corp. | 2003 | — |
| −1 | K040531 | Terumo SURGUARD2 Safety Needle | Terumo Medical Corp. | 2004 | — |
| 0 (this device) | K082908 | Novaguard, Model 3611001 | West Pharmaceutical Services, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K043397 | Modification to BD Eclipse Hypodermic NeedleSummary page 1…needle protection device Predicate devices: BD ECLIPSETM HYPODERMIC NEEDLE 5 10(k) No. K043397 Becton, Dickinson & Company S… | 2004 |
| * | K951254 | Safetyglide NeedleSummary page 1…Becton, Dickinson & Company SATETYGLIDE TMNEEDLE 510(k) No. K951254 Becton, Dickinson Vacutainer Systems Preanalytical… | 1995 |
| * | K012736 | Monoject Safety NeedleSummary page 1…Solutions MONOJECTr SAFETY NEEDLE 510(k) No. K012736 Tyco Healthcare (Covidien) TE… | 2001 |
| * | K040531 | Terumo SURGUARD2 Safety NeedleSummary page 1…Healthcare (Covidien) TERUMO SURGUARD2 TM SAFETY NEEDLE 5 10O(k) No. K040531 Temumo Medical Corp Manufacturer: West Phar… | 2004 |
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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 5 of the 13 ancestors have a recall of any class.
- 2 other devices also cite its predicate K043397.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 primary function of the NOVAguard MT Safety Needle is for the injection of fluids into or withdrawal of fluids from parts of the body below the surface of the skin. The needle stick prevention feature helps prevent accidental needle sticks by shielding the needle after use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082908 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082908: Novaguard, Model 3611001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082908
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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