510(k) · Cleared
ClearedDropSafeTM SicuraTM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pikdare Spa · FMI Needle, Hypodermic, Single Lumen
Cleared on Dec 2, 2022 as substantially equivalent to K111797 (Terumo Europe N.V., 2011) after a 30-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Dec 2, 2022
- Review
- 30 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K904198 (1990). 15 ancestors in all, the oldest K771205 (1977). No later device cites it as a predicate yet.
- Root · 7 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 6 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 5 generations backK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
- 4 generations backK040531 Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004
- 3 generations backK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005
- 2 generations backK110527 K-Pack Surshield Needle, Hypodermic Needle for Single UseTerumo Europe N.V. · 2011
- 1 generation backK111797 27 G X 1/2 K-Pack Surshield NeedleTerumo Europe N.V. · 2011
- This deviceK223353 DropSafeTM SicuraTMPikdare Spa · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −6 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| −5 | K031453 | Terumo Surguard 2 Safety Needle | Terumo Medical Corp. | 2003 | — |
| −4 | K040531 | Terumo SURGUARD2 Safety Needle | Terumo Medical Corp. | 2004 | — |
| −3 | K051865 | Terumo Surguard 2 Safety Needle or Similar | Terumo Medical Corp. | 2005 | — |
| −2 | K110527 | K-Pack Surshield Needle, Hypodermic Needle for Single Use | Terumo Europe N.V. | 2011 | — |
| −1 | K111797 | 27 G X 1/2 K-Pack Surshield Needle | Terumo Europe N.V. | 2011 | — |
| 0 (this device) | K223353 | DropSafeTM SicuraTM | Pikdare Spa | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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? (1)
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 |
|---|---|---|---|
| * | K111797 | 27 G X 1/2 K-Pack Surshield NeedleSummary page 5…Manufacturer Trade Name 510(k) Number Terumo Europe NV K-pack SurshieldTM K111797 Description of Device: [807.92(a)(4)] Device description DropSafeTM SicuraTM are Sterile, single-use passive safety… | 2011 |
| † | K051865 | Terumo Surguard 2 Safety Needle or Similar | 2005 |
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 32 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 4 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K111797.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 DropSafeTM SicuraTM are sterile, single-use passive safety injection needles to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223353 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223353: DropSafeTM SicuraTM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223353
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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