510(k) Report

510(k) · Cleared

Cleared

AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray

K172062510(k) TraditionalCleared Mar 5, 2018241-day reviewClass II21 CFR 880.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medscience Science Research Group, Inc. · SCL Allergen And Vaccine Delivery Needles

Cleared on Mar 5, 2018 as substantially equivalent to K003195 (Greer Laboratories, Inc., 2000) after a 241-day review. Its family tree reaches back 1 generation to 2000.

Decided
Mar 5, 2018
Review
241 days
Class
Class II
Product code
SCL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003195 (2000). No later device cites it as a predicate yet.

K003195 · Greertrack Skin Testing System, Model GT-IT, GT-IC · Greer Laboratories, Inc. · 200020002005201020152020
K003195 · Greertrack Skin Testing System, Model GT-IT, GT-IC · Greer Laboratories, Inc. · 20000
  1. Root · 1 generation backK003195 Greertrack Skin Testing System, Model GT-IT, GT-ICGreer Laboratories, Inc. · 2000
  2. This deviceK172062 AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9…Medscience Science Research Group, Inc. · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003195Greertrack Skin Testing System, Model GT-IT, GT-ICGreer Laboratories, Inc.2000—
0 (this device)K172062AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well…Medscience Science Research Group, Inc.2018—
FIG. 1 — Lineage of K172062, 2000–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250983 Medblue Skin Prick Test Applicator (AS103…score 11.1 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K003195Greertrack Skin Testing System, Model GT-IT, GT-IC
Summary page 6
…Classification Panel: General Hospital Page 1 of 9 5. Legally Marketed Predicate Device(s) K003195, Greertrack Skin Testing System, currently marked by Greer under the brand name Skintestor OMNI™. 6. Indication for Use State…
Greer Laboratories, Inc.2000—

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.

How does its category compare?

All SCL devices

SCL Allergen And Vaccine Delivery Needles: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · SCL

1in 2022

2017: 12018: 12019: 12022: 12026 (partial year): 1
2007high 1 (2017) · low 0 (2007)2026

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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20171—00
20181—00
20191—00
20200—00
20210—00
20221—00
20230—00
20240—00
20250—00
20261—0—

What is it indicated for?

The skin test applicator is used for conventional administration (percutaneous application of allergenic extracts directly onto the surface of the skin) of diagnostic allergen extracts for performing allergy skin tests on the typical sites (the back and the volar surfaces of the forearms) for hypersensitivity reactions in individuals suspected of having allergies.

The test tray is intended to hold allergenic extracts in a convenient arrangement for storage and use by the clinician.

Indications for use as stated in the FDA summary.

Recent decisions in SCL

The SCL category page

  • K250983Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148…Asistan Medikal · 2026
  • K222385Bifurcated NeedleAnhui Tiankang Medical Technology Co., Ltd. · 2022
  • K182582Oryum and Ovem Epidermal Deri Prick Test ApplicatorAllergy & Applicator Depot, LLC · 2019
  • K162917Allerhope Allergy Skin TesterProcare Industrial Co., Limited · 2017
  • K032528BD Eclipse Bifurcated NeedleBecton, Dickinson & CO · 2003

https://510kreport.com/device/K172062 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172062: AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172062

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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