510(k) · Cleared
ClearedDermapik II Skin Test System, Dermapik II (Single Test Device), Polypik II (Multiple Skin Test Device), Dermapik Tray, D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedex, Inc. · SCL Allergen And Vaccine Delivery Needles
Cleared on Apr 28, 2000 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 28, 2000
- Review
- 88 days
- Class
- Class II
- Product code
- SCL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
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.
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?
DermaPik II Skin Test System™ is an allergen skin test device and supporting components designed to apply allergen test extract using the puncture technique. DermaPik II Skin Test System™ is designed for use by allergy practitioners who are trained in the application and interpretation of the puncture test technique and who are trained in the recognition and treatment of adverse allergic reactions should they occur. Clinical settings appropriate for use…
Read the full statement (133 words)
DermaPik II Skin Test System™ is an allergen skin test device and supporting components designed to apply allergen test extract using the puncture technique.
DermaPik II Skin Test System™ is designed for use by allergy practitioners who are trained in the application and interpretation of the puncture test technique and who are trained in the recognition and treatment of adverse allergic reactions should they occur.
Clinical settings appropriate for use of this system would include professional medical environments such as physician clinics and hospitals.
The target population appropriate for use of this system would include both pediatric and adult patients.
As is common in all allergy skin test procedures, this device is appropriate for use on the forearms or back in accordance with commonly accepted practices of physicians trained in allergy skin testing.
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/K000299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000299: Dermapik II Skin Test System, Dermapik II (Single Test Device), Polypik II (Multiple Skin Test Device), Dermapik Tray, D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000299
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026