510(k) · Cleared
ClearedMulti-Test II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lincoln Diagnostics, Inc. · SCL Allergen And Vaccine Delivery Needles
Cleared on Aug 7, 1996 after an 82-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Aug 7, 1996
- Review
- 82 days
- Class
- Class II
- Product code
- SCL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK961918 Multi-Test IILincoln Diagnostics, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK182582 Oryum and Ovem Epidermal Deri Prick Test ApplicatorAllergy & Applicator Depot, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK250983 Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110…Asistan Medikal · 2026
- Descendant · cites it directly · 0 of its ownK162917 Allerhope Allergy Skin TesterProcare Industrial Co., Limited · 2017
Most influential descendants
Showing 3 of 3 · See all- K182582Oryum and Ovem Epidermal Deri Prick Test ApplicatorAllergy & Applicator Depot, LLC · 2019 · cites it directly1descendant
- K250983Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132…Asistan Medikal · 2026 · 2 generations on0descendants
- K162917Allerhope Allergy Skin TesterProcare Industrial Co., Limited · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961918 | Multi-Test II | Lincoln Diagnostics, Inc. | 1996 | — |
| +1 | K182582 | Oryum and Ovem Epidermal Deri Prick Test Applicator | Allergy & Applicator Depot, LLC | 2019 | — |
| +2 | K250983 | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113… | Asistan Medikal | 2026 | — |
| +1 | K162917 | Allerhope Allergy Skin Tester | Procare Industrial Co., Limited | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 1 | 0 |
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 SCL? 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 SCL device
- #1 K250983 Medblue Skin Prick Test Applicator (AS103…score 11.1 · 2 generations · no Class I recall
- #2 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? (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?
- Of its descendants, K182582 (Allergy & Applicator Depot, LLC, 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All SCL devicesSCL Allergen And Vaccine Delivery Needles: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · SCL
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · SCL
Too few SCL 510(k)s in any year since 2007 to give a median.
Recalls per year · SCL
No recall names SCL since 2007.
Adverse event reports per year · SCL
No MAUDE report names SCL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The sole indication for Multi-Test II is for the percutaneous administration of diagnostic allergenic extracts.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961918: Multi-Test II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961918
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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