510(k) · Cleared
ClearedIntradermal Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
West Pharmaceutical Services, Inc. · FMF Syringe, Piston
Cleared on Feb 19, 2013 as substantially equivalent to K941657 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1994) after a 90-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Feb 19, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941657 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK941657 BD Micro Fine, Ultra Fine, and Allergy SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
- This deviceK123588 Intradermal AdapterWest Pharmaceutical Services, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK181369 Immucise Intradermal Injection SystemTerumo Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK190427 ImmuciseTerumo Corporation · 2019
- Descendant · cites it directly · 0 of its ownK151777 Intradermal AdapterWest Pharmaceutical Services, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941657 | BD Micro Fine, Ultra Fine, and Allergy Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | — |
| 0 (this device) | K123588 | Intradermal Adapter | West Pharmaceutical Services, Inc. | 2013 | — |
| +1 | K181369 | Immucise Intradermal Injection System | Terumo Corporation | 2018 | — |
| +2 | K190427 | Immucise | Terumo Corporation | 2019 | — |
| +1 | K151777 | Intradermal Adapter | West Pharmaceutical Services, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 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 |
|---|---|---|---|
| * | K941657 | BD Micro Fine, Ultra Fine, and Allergy SyringeSummary page 1….: 21 CFR 880.5860 Class: 11 Panel Identification: General Hospital Predicate Devices: K94 1657 RD-Microfine, Ultrafine; and Allergy Syringe Device Description: The Intradermal Adapter consists of a single injection mol… | 1994 |
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?
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The Intradermal Adapter is an accessory to a I ml, /2 inch fixed-needle allergy syringe indicated for use as a guide for performing intradermal injections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123588: Intradermal Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123588
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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