FDA product code SCL: Allergen And Vaccine Delivery Needles
SCL is the FDA product code for allergen and vaccine delivery needles. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel. FDA has cleared 25 510(k) submissions under SCL, 2 in the last five years, from 22 different applicants. The average 510(k) review took 139 days (median 99); 305 days on average over the last three years.
Definition
An allergen delivery needle is a device intended to percutaneously deliver diagnostic allergenic extracts for use in allergy skin tests also referred to as skin prick tests or intradermal allergy tests.
Classification
| Field | Value |
|---|---|
| Device name | Allergen And Vaccine Delivery Needles |
| Device class | Class II |
| Regulation | 21 CFR 880.5570 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for SCL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 303 |
| 2018 | 1 | 241 |
| 2019 | 1 | 203 |
| 2022 | 1 | 120 |
| 2026 | 1 | 305 |
Compare with all 510(k) review times · Search every SCL clearance
Top SCL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Precision Medical Products, Inc. | 2 | 2003-08-07 |
| Greer Laboratories, Inc. | 2 | 2000-12-13 |
| Lincoln Diagnostics, Inc. | 2 | 1996-08-07 |
| Asistan Medikal | 1 | 2026-01-30 |
| Anhui Tiankang Medical Technology Co., Ltd. | 1 | 2022-12-06 |
17 more applicants have SCL clearances. See the full list in Caduvo.
Most recent SCL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250983 | Asistan Medikal | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) | 2026-01-30 | 305 |
| K222385 | Anhui Tiankang Medical Technology Co., Ltd. | Bifurcated Needle | 2022-12-06 | 120 |
| K182582 | Allergy & Applicator Depot, LLC | Oryum and Ovem Epidermal Deri Prick Test Applicator | 2019-04-10 | 203 |
| K172062 | Medscience Science Research Group, Inc. | AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray | 2018-03-05 | 241 |
| K162917 | Procare Industrial Co., Limited | Allerhope Allergy Skin Tester | 2017-08-17 | 303 |
Recalls for SCL devices
openFDA lists no recalls for product code SCL.
Frequently asked questions
What is FDA product code SCL?
SCL is the FDA product code for allergen and vaccine delivery needles. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel.
What device class is SCL?
Class II, regulation 21 CFR 880.5570. Typical premarket route: 510(k).
How long does a 510(k) take for product code SCL?
Across 25 cleared submissions the average was 139 days from receipt to decision (median 99).
Which companies have the most SCL clearances?
Precision Medical Products, Inc. (2); Greer Laboratories, Inc. (2); Lincoln Diagnostics, Inc. (2); Asistan Medikal (1); Anhui Tiankang Medical Technology Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SCL
- Run a recall and safety report across every SCL manufacturer
- Watch product code SCL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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