510(k) · Cleared
ClearedImmucise Intradermal Injection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Corporation · FMI Needle, Hypodermic, Single Lumen
Cleared on Nov 13, 2018 as substantially equivalent to K052034 (Terumo Medical Corp., 2005) and 1 other predicate after a 174-day review. Its family tree reaches back 4 generations to 1977. 1 later device descends from it.
- Decided
- Nov 13, 2018
- Review
- 174 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K771205 (1977). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 3 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 2 generations backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- 1 generation backK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- This deviceK181369 Immucise Intradermal Injection SystemTerumo Corporation · 2018
- Descendant · cites it directly · 0 of its ownK190427 ImmuciseTerumo Corporation · 2019
Most influential descendants
Showing 1 of 1 · See all- K190427ImmuciseTerumo Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −3 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −2 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| −1 | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| 0 (this device) | K181369 | Immucise Intradermal Injection System | Terumo Corporation | 2018 | — |
| +1 | K190427 | Immucise | Terumo Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K052034 | Terumo Syringe with/Without NeedleSummary page 5…Syringe) Classification: Class II C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed devices to which substantial equivalences are claimed are: K052034 – Terumo Syringe with/without Needle, manufactured by Terumo (Philippines) Corporation – Primary Predicate… | 2005 |
| * | K123588 | Intradermal AdapterSummary page 5…ences are claimed are: K052034 – Terumo Syringe with/without Needle, manufactured by Terumo (Philippines) Corporation – Primary Predicate K123588 – Intradermal Adapter manufactured by West Pharmaceutical Services, Inc. Note: Terumo Corporation has establ… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190427 | Immucise | 2019 | 0 |
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 41 years and passes through 3 companies; a new generation was cleared every 13.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K190427 (Terumo Corporation, 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K052034.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Immucise Intradermal Injection System is indicated for intradermal injections of FDA approved drugs. The system is to be used in the deltoid region for adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181369: Immucise Intradermal Injection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181369
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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