510(k) · Cleared
ClearedMedblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asistan Medikal · SCL Allergen And Vaccine Delivery Needles
Cleared on Jan 30, 2026 as substantially equivalent to K182582 (Allergy & Applicator Depot, LLC, 2019) after a 305-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Jan 30, 2026
- Review
- 305 days
- Class
- Class II
- Product code
- SCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961918 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961918 | Multi-Test II | Lincoln Diagnostics, Inc. | 1996 | — |
| −1 | K182582 | Oryum and Ovem Epidermal Deri Prick Test Applicator | Allergy & Applicator Depot, LLC | 2019 | — |
| 0 (this device) | K250983 | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113… | Asistan Medikal | 2026 | — |
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 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 K222385 Bifurcated Needlescore 4.8 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K182582 | Oryum and Ovem Epidermal Deri Prick Test ApplicatorSummary page 5…on Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: SCL Predicate Device: Oryum and Ovem Epidermal Deri Skin Prick Test Applicator (K182582) Page 1 of 6 Predicate Device The subject device claims equivalen… | 2019 |
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 30 years and passes through 3 companies; a new generation was cleared every 22.7 years on median.
- None of the 2 ancestors has a recall.
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. 2026, this device’s year, is highlighted.
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?
Used for percutaneous administration of diagnostic allergenic extracts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250983: Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250983
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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