510(k) · Cleared
ClearedAllerhope Allergy Skin Tester
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Procare Industrial Co., Limited · SCL Allergen And Vaccine Delivery Needles
Cleared on Aug 17, 2017 as substantially equivalent to K961918 (Lincoln Diagnostics, Inc., 1996) after a 303-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Aug 17, 2017
- Review
- 303 days
- Class
- Class II
- Product code
- SCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961918 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK961918 Multi-Test IILincoln Diagnostics, Inc. · 1996
- This deviceK162917 Allerhope Allergy Skin TesterProcare Industrial Co., Limited · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961918 | Multi-Test II | Lincoln Diagnostics, Inc. | 1996 | — |
| 0 (this device) | K162917 | Allerhope Allergy Skin Tester | Procare Industrial Co., Limited | 2017 | — |
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 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? (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 |
|---|---|---|---|
| * | K961918 | Multi-Test IISummary page 5…vice(s) The identified predicate within this submission is as follows: The Multi-Test II of Lincoln Diagnostics, Incorporated have been cleared by FDA through 510(k) No. K961918 (Decision Date – Aug 7, 1996). 510(k) Summary 2-4 === Pa… | 1996 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K961918.
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. 2017, 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?
The Allerhope® Allergy Skin Tester is for the percutaneous administration of diagnostic allergenic extracts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162917: Allerhope Allergy Skin Tester.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162917
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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